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Trial record 1 of 2 for:    photobiomodulation | TBI
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Photobiomodulation to Improve Cognition in TBI, With fMRI

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ClinicalTrials.gov Identifier: NCT04230577
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
VA Boston Healthcare System
Vielight Inc.
Information provided by (Responsible Party):
Boston VA Research Institute, Inc.

Brief Summary:
The purpose of this small, research study is to examine effectiveness of an at-home application of an experimental intervention, on thinking and memory in mild-moderate, closed-head, traumatic brain injury cases. The experimental intervention is light-emitting diode (LED) therapy, which is applied to the scalp and through the nose using a head frame device. Participants are expected to complete two, 5-week series of LED treatments, at home, 3 times a week. There will be a 1-month period between the two series. Each home treatment is 20 minutes. Participants will be trained to use the head frame device, in-office. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. A two-hour paper and pencil testing (4 visits) and a one-hour MRI (3 visits) will be administered before and after each treatment series. Participants may be in the study for about 4 months. This study is supported by Vielight, Inc., Hayward, CA/ Toronto, Canada

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Closed Head Injury Cognitive Dysfunction Device: Real LED Intervention Device: Sham LED Intervention Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study is a blinded, randomized, sham-controlled, partial-crossover study with 2 groups (n=10 per group (Sham, Real); ages 18-65). Participants are randomized by computer into group 1 or 2, in blocks of 10. At-home LED intervention is self-administered 3 times per week (20 minutes), for two 5-week series, with a one month break between series. All participants receive a Real Series of treatment at some point during the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: After consent/screening participant is randomized by computer into Group 1 or Group 2 in blocks of 10. The participant, investigator and outcome assessor is blinded to Group.
Primary Purpose: Treatment
Official Title: Transcranial Photobiomodulation to Improve Cognition in TBI, With Pre-/Post- fMRI Scans: A Pilot, Sham-Controlled Study
Actual Study Start Date : August 7, 2019
Estimated Primary Completion Date : July 29, 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Active Comparator: Real LED Intervention
Participants receive 15 Real (active) LED treatments with the Vielight Neuro Alpha head frame device (with intranasal). Parameters: NIR, 810nm, pulsed at 10 Hz, 50% duty cycle, synchronized for a 20-minute treatment time. Total Energy Dose per head set plus intranasal: 225 J/cm2+ 15 J/cm2 = 240 J/cm2 per 20 min LED treatment. Total Energy Dose delivered (3x/Week, 5 Weeks) = 3600 J/cm2. The light from these LEDs is not visible to the eye. There is no potential for eye damage because the LEDs are not laser light. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. It is approved for use by the VA Boston Healthcare System Safety Committee and Institutional Review Board.
Device: Real LED Intervention
A series of Real at-home, transcranial LED treatments (3xWeek, 5 weeks), 20-minute treatment, 810nm (NIR), Vielight Neuro Alpha Head Frame Device (with NIR intranasal).
Other Names:
  • Light-Emitting Diode (LED) Therapy
  • Photobiomodulation (PBM)
  • Vielight Neuro Alpha

Sham Comparator: Sham LED Intervention
Participants receive a series of 15 Sham (control) LED treatments with the Vielight Neuro Alpha head frame device (with intranasal) containing Sham LEDs, synchronized for a 20-minute treatment time (3x/Week, 5 Weeks). Sham and Real devices are identical in look and feel, except no photons are emitted from the Sham devices.
Device: Real LED Intervention
A series of Real at-home, transcranial LED treatments (3xWeek, 5 weeks), 20-minute treatment, 810nm (NIR), Vielight Neuro Alpha Head Frame Device (with NIR intranasal).
Other Names:
  • Light-Emitting Diode (LED) Therapy
  • Photobiomodulation (PBM)
  • Vielight Neuro Alpha

Device: Sham LED Intervention
A series of Sham at-home, transcranial LED treatments (3xWeek, 5 weeks), 20-minute treatment, Vielight Neuro Alpha Head Frame Device (with intranasal) with Sham LEDs that emit no photons. Sham and Real Devices look and feel identical.
Other Name: Control




Primary Outcome Measures :
  1. CVLT-II, Long Delay Free Recall 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.

    Alternate lists are used at each testing timepoint to avoid practice effect


  2. CVLT-II, Long Delay Free Recall 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.

    Alternate lists are used at each testing timepoint to avoid practice effect


  3. CVLT-II, Long Delay Free Recall 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]

    California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.

    Alternate lists are used at each testing timepoint to avoid practice effect


  4. CVLT-II, Long Delay Free Recall 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.

    Alternate lists are used at each testing timepoint to avoid practice effect



Secondary Outcome Measures :
  1. CVLT-II, Short Delay Free Recall 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled.

  2. CVLT-II, Short Delay Free Recall 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled.

  3. CVLT-II, Short Delay Free Recall 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled.

  4. CVLT-II, Short Delay Free Recall 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    California Verbal Learning Test-II Immediate Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome Participant is asked to recall items from List A. Total is number of words recalled.

  5. CVLT-II, Short Delay Cued Recall 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  6. CVLT-II, Short Delay Cued Recall 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  7. CVLT-II, Short Delay Cued Recall 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  8. CVLT-II, Short Delay Cued Recall 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    California Verbal Learning Test-II Immediate Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  9. CVLT-II, Long Delay Cued Recall 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  10. CVLT-II, Long Delay Cued Recall 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  11. CVLT-II, Long Delay Cued Recall 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  12. CVLT-II, Long Delay Cued Recall 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    California Verbal Learning Test-II Long Delay (20 minutes) Cued Recall; Measures Verbal Memory Participants are asked to immediately recall items from a list, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.

  13. CVLT-II, Total Trials 1-5 _1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored.

  14. CVLT-II, Total Trials 1-5 _2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored.

  15. CVLT-II, Total Trials 1-5 _3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored.

  16. CVLT-II, Total Trials 1-5 _4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    California Verbal Learning Test-II, Total Trials 1-5; Measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored.

  17. Color-Word Interference (Stroop) Test, Trial 3 _1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.

    Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible.


  18. Color-Word Interference (Stroop) Test, Trial 3 _2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.

    Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible.


  19. Color-Word Interference (Stroop) Test, Trial 3 _3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.

    Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible.


  20. Color-Word Interference (Stroop) Test, Trial 3 _4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 3 is a measure of Inhibition.

    Measures Attention/Executive Function; inhibition Measure is Reaction Time lower = better outcome Trial 3 (Inhibition): Name the color ink each word is printed in for a series of words, as quickly as possible.


  21. Color-Word Interference (Stroop) Test, Trial 4 _1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.

    Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible


  22. Color-Word Interference (Stroop) Test, Trial 4 _2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.

    Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible


  23. Color-Word Interference (Stroop) Test, Trial 4 _3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.

    Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible


  24. Color-Word Interference (Stroop) Test, Trial 4 _4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Delis-Kaplan Executive Function (DKEFS), Color-Word Interference Test; also known as the Stroop test; Trial 4 is a measure of executive function: Inhibition/switching.

    Measures Attention/Executive Function; inhibition/switching Measure is Reaction Time lower = better outcome Trial 4 (Inhibition and Switching): Name the color of the ink, however if there is a box around the word, read the word, as quickly as possible


  25. Delis-Kaplan Executive Function Trails (Condition 2) 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible.

  26. Delis-Kaplan Executive Function Trails (Condition 2) 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible.

  27. Delis-Kaplan Executive Function Trails (Condition 2) 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible.

  28. Delis-Kaplan Executive Function Trails (Condition 2) 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    Number Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible.

  29. Delis-Kaplan Executive Function Trails (Condition 4) 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible.

  30. Delis-Kaplan Executive Function Trails (Condition 4) 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible.

  31. Delis-Kaplan Executive Function Trails (Condition 4) 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible.

  32. Delis-Kaplan Executive Function Trails (Condition 4) 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    Number and Letter Sequencing; measures Attention/Executive Function, Sequencing, Visual Scanning Measure is Reaction Time with lower = better outcome Alternate connecting numbers and letters in consecutive order from 1 to P (1-A-2-B…) as quickly as possible.

  33. Benton Visual Memory Test; Trial 1 Immediate Recall 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.

    Total possible 12 points


  34. Benton Visual Memory Test; Trial 1 Immediate Recall 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.

    Total possible 12 points


  35. Benton Visual Memory Test; Trial 1 Immediate Recall 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]

    Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.

    Total possible 12 points


  36. Benton Visual Memory Test; Trial 1 Immediate Recall 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Immediate Recall for Visuospatial memory Min 0 and max 36; higher score better outcome Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.

    Total possible 12 points


  37. Benton Visual Memory Test; Total Trials 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.


  38. Benton Visual Memory Test; Total Trials 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.


  39. Benton Visual Memory Test; Total Trials 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]

    Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.


  40. Benton Visual Memory Test; Total Trials 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Total Trials 1-3. Learning Measure for Visuospatial memory Min 0 and max 36; higher score better outcome Total possible for each trial is 12 points. Sum of Total is learning score. Participant is presented with 6 figures. They are given 10 secs to view 6 pictures. Immediately asked to recall and draw the figures. This is repeated 3 times.

    Up to 2 points per figure. Scoring based on accuracy and placement of figure parts: A score of 0, 1 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable.


  41. Benton Visual Memory Test; Delayed Recall 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).

    Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure.


  42. Benton Visual Memory Test; Delayed Recall 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).

    Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure.


  43. Benton Visual Memory Test; Delayed Recall 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]

    Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).

    Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure.


  44. Benton Visual Memory Test; Delayed Recall 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Measures Delayed (20 minute) Recall for Visuospatial memory. {participant completes other tasks during delay) Min 0 and max 12; higher score better outcome Participant is asked to draw the figures from memory after a 20 minute delay (other tasks completed during this time).

    Total possible: 12 Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, 1 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per figure.


  45. Beck Depression Inventory (BDI) 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3.

  46. Beck Depression Inventory (BDI) 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3.

  47. Beck Depression Inventory (BDI) 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3.

  48. Beck Depression Inventory (BDI) 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    21 item Questionnaire; Measures mood symptoms. Min 0 and max 63 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3.

  49. Post Traumatic Stress Disorder (PCL) 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item.

  50. Post Traumatic Stress Disorder (PCL) 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item.

  51. Post Traumatic Stress Disorder (PCL) 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item.

  52. Post Traumatic Stress Disorder (PCL) 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    17-item, symptom questionnaire Higher scores indicates greater endorsement of symptoms Min 17 and max 85 Reliable decrease 5-10 Clinically meaningful decrease 10-20 points Lower scores = better outcome Score ranges from 1-5 for each item.

  53. Visual Analog Pain Rating Scale (VAS) 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10.

  54. Visual Analog Pain Rating Scale (VAS) 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10.

  55. Visual Analog Pain Rating Scale (VAS) 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
    Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10.

  56. Visual Analog Pain Rating Scale (VAS) 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    Current Pain Rating scale of 1-10 Lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10.

  57. Short Form, McGill Pain Questionnaire 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).

    Sum totaled for all categories


  58. Short Form, McGill Pain Questionnaire 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).

    Sum totaled for all categories


  59. Short Form, McGill Pain Questionnaire 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]

    Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).

    Sum totaled for all categories


  60. Short Form, McGill Pain Questionnaire 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Pain Rating (for the last 30 days) Min 0 and max 45; lower = better outcome Participant rates 15 categories of pain type (None = 0, mild = 1, moderate = 2, severe = 3).

    Sum totaled for all categories


  61. Pittsburgh Sleep Quality Index (PSQI) 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome

  62. Pittsburgh Sleep Quality Index (PSQI) 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome

  63. Pittsburgh Sleep Quality Index (PSQI) 3 [ Time Frame: Change from 1-Week to 1-Month after Series ]
    9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome

  64. Pittsburgh Sleep Quality Index (PSQI) 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    9 item questionnaire- made up of 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) Min of 0 and max of 3 per component. Global Sleep Score is total of 7 components Min score of 0 and max score of 21; lower score = better outcome

  65. Quality of Community Integration Questionnaire Total CIQ Score 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.

    Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29


  66. Quality of Community Integration Questionnaire Total CIQ Score 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.

    Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29


  67. Quality of Community Integration Questionnaire Total CIQ Score 3 [ Time Frame: Change from 1-Week to 1-Month after Series ]

    CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.

    Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29


  68. Quality of Community Integration Questionnaire Total CIQ Score 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    CIQ Cognitive Integration Score: 22 Questions Higher Score = better outcome Participant self-report of Current Level of Functional independence and satisfaction level of that ability on various cognitive and social/work/family interactions.

    Score 0-2 points for each item Composite Score: Sum of Home Integration 5 items, Social Integration 6 items and Productivity Scores 2 items; Range 0-29


  69. Quality of Community Integration Questionnaire (QCIQ) Score 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome

  70. Quality of Community Integration Questionnaire (QCIQ) Score 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome

  71. Quality of Community Integration Questionnaire (QCIQ) Score 3 [ Time Frame: Change from 1-Week to 1-Month after Series ]
    Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome

  72. Quality of Community Integration Questionnaire (QCIQ) Score 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    Quality of Community Integration (QCIQ) Score (Patient Satisfaction Level) 0-4 for satisfaction level on each item Range: 9 - 36 (Self-Report of satisfaction of home and social integration and productivity Higher Score = better outcome

  73. Quality of Community Integration Questionnaire Cognitive Satisfaction Score 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24

  74. Quality of Community Integration Questionnaire Cognitive Satisfaction Score 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24

  75. Quality of Community Integration Questionnaire Cognitive Satisfaction Score 3 [ Time Frame: Change from 1-Week to 1-Month after Series ]
    Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24

  76. Quality of Community Integration Questionnaire Cognitive Satisfaction Score 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    Cognitive Satisfaction Score: Sum of 6 items related to cognitive satisfaction Range 6 - 24

  77. Quality of Community Integration Questionnaire Cognitive Quality of Life Score 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Cognitive Quality of Life Score:

    Cognitive Satisfaction Score x score on item 16. Range: 6 - 72


  78. Quality of Community Integration Questionnaire Cognitive Quality of Life Score 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Cognitive Quality of Life Score:

    Cognitive Satisfaction Score x score on item 16. Range: 6 - 72


  79. Quality of Community Integration Questionnaire Cognitive Quality of Life Score 3 [ Time Frame: Change from 1-Week to 1-Month after Series ]

    Cognitive Quality of Life Score:

    Cognitive Satisfaction Score x score on item 16. Range: 6 - 72


  80. Quality of Community Integration Questionnaire Cognitive Quality of Life Score 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Cognitive Quality of Life Score:

    Cognitive Satisfaction Score x score on item 16. Range: 6 - 72


  81. Dysexecutive Functional Index (DEX) 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]

    Self-Report of psychosocial problems that participant may be experiencing in everyday life.

    20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome


  82. Dysexecutive Functional Index (DEX) 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]

    Self-Report of psychosocial problems that participant may be experiencing in everyday life.

    20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome


  83. Dysexecutive Functional Index (DEX) 3 [ Time Frame: Change from 1-Week to 1-Month after Series ]

    Self-Report of psychosocial problems that participant may be experiencing in everyday life.

    20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome


  84. Dysexecutive Functional Index (DEX) 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

    Self-Report of psychosocial problems that participant may be experiencing in everyday life.

    20 Questions Scale of 0-4 for each item Total Possible: 80 Lower Score = better outcome


  85. Tinnitus Functional Index 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
    25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress

  86. Tinnitus Functional Index 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
    25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress

  87. Tinnitus Functional Index 3 [ Time Frame: Change from 1-Week to 1-Month after Series ]
    25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress

  88. Tinnitus Functional Index 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]
    25 items; rated on a scale of 1-10 Lower score = better outcome Max = 10 per item; Max possible =250 overall Average across all valid responses Overall Score = Average*10 Max of 19 items must be marked >0 to be valid for tinnitus Subscores (each 3-4 items totaled) address 8 domains related to negative impact of tinnitus Intrusive, Sense of Control, Cognitive, Sleep, Auditory Difficulties, Relaxation, Quality of Life, and Emotional Distress



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years old
  • Must have had one (or more) closed-head, traumatic brain injuries
  • Loss of consciousness 24 hours or less; or no loss of consciousness/ A period of altered mental status (post-traumatic amnesia)/mental confusion for 24 hours or less
  • Must be able to come to VA Boston Healthcare System, Jamaica Plain Campus for testing visits and Boston University Center for Biomedical Imaging, Boston University School of Medicine for MRI scans

Must meet the following Screening requirements:

  • Participants must score at least 2 SD below normal on at least 1 of the NP tests; or 1 SD below on at least 2 of these NP tests administer at Entry testing: Trail Making Test A & B; Controlled Oral Word Association Test (COWAT/FAS); California Verbal Learning Test II; DKEFS Color-Word Interference Test (Stroop).

Exclusion Criteria:

  • Diagnosis of a neurological disease such amyotrophic lateral sclerosis (ALS), Parkinson's, Alzheimer's disease
  • History of craniotomy or craniectomy
  • A current life-threatening disease such as cancer
  • Disease requiring organ transplant
  • A severe mental disorder such as schizophrenia, bipolar disorder (not associated with clinically diagnosed PTSD)
  • Current substance abuse or active treatment; within the last 6 months
  • The Test of Memory Malingering is administered at screening; Participants must not have scores that indicate evidence of malingering, a score of less than 45 on either Part 1 or 2 would show evidence of malingering, with the following exception: If a participant fails Trial 1, but does not fail Trial 2, he/she would not be excluded if he/she also show evidence of poor learning on other NP Screening tests, such as the CVLT. If he/she fails Trial 2, alone, or Trial 1 and Trial 2, then this would exclude the participant from the study.
  • Self-reported pain questionnaires (VAS Pain Rating and the Short Form McGill Pain Questionnaire) are also administered. Participants may not have a level of pain greater than 7/10 on VAS or 38/50 on the McGill pain questionnaires at the time of screening.

Exclusion for Magnetic Resonance Imaging Only

  • A BU MRI safety screening form will be reviewed at the time of study screening, as well as at each MRI scan appointment to ensure the participant can safely have an MRI. Participants must tell the investigator about any operations and any metal in his/her body, so it can be decided if it is safe for you to proceed with the scan.

Participants cannot have a MRI scan:

  • if pregnant.
  • if he/she has pacemakers, ear implants, shrapnel injuries, or other types of metal or electric device in their body

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230577


Contacts
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Contact: Paula I Martin, PhD 857-364-4029 Paula.Martin@va.gov
Contact: Michael Ho, PhD 857-364-2213 Michael.Ho3@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Paula I Martin, PhD    857-364-2631    paulak@bu.edu   
Contact: Margaret Naeser, PhD    857-364-4030    mnaeser@bu.edu   
Sponsors and Collaborators
Boston VA Research Institute, Inc.
VA Boston Healthcare System
Vielight Inc.
Investigators
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Principal Investigator: Paula I Martin, PhD VA Boston Healthcare System, Jamaica Plain Campus, Boston, Ma

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Responsible Party: Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT04230577    
Other Study ID Numbers: 0216aVielight
3223 ( Other Identifier: VABHS )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-Identified data may be shared with written request and permission from VA Boston Healthcare System Internal Review Board, and Privacy Official.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston VA Research Institute, Inc.:
mild-moderate traumatic brain injury
TBI
Photobiomodulation (PBM)
Cognition
Executive Function
Attention
Memory
Low-level Laser Therapy (LLLT)
Light-Emitting Diodes (LEDs)
Magnetic Resonance Imaging (MRI)
functional MRI (fMRI)
resting-state functional connectivity MRI (rs-fcMRI)
Magnetic Resonance Spectroscopy (MRS)
Post Traumatic Stress Disorder (PTSD)
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Head Injuries, Closed
Cognitive Dysfunction
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Wounds, Nonpenetrating