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Trial record 2 of 5 for:    photobiomodulation | TBI

Photobiomodulation for Concussions: the Use of the ImPACT® Test as an Assessment Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823507
Recruitment Status : Completed
First Posted : March 30, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Meditech Rehabilitation Centre

Tracking Information
First Submitted Date March 29, 2021
First Posted Date March 30, 2021
Last Update Posted Date April 1, 2021
Actual Study Start Date March 26, 2021
Actual Primary Completion Date March 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2021)
Improvement in ImPACT test scores after treatment with Photobiomodulation. [ Time Frame: 4 weeks ]
• Statistically significant change in measured metrics for Workplace Post injury 2 ImPACT® outcome scores compared to Workplace Post injury 1 ImPACT® scores for patients in the study population.
Original Primary Outcome Measures
 (submitted: March 29, 2021)
Improvement in ImPACT test scores after treatment with Photobiomodulation. [ Time Frame: 4 weeks ]
• Statistically significant improvement in measured metrics for Workplace Post injury 2 ImPACT® outcome scores compared to Workplace Post injury 1 ImPACT® scores for patients in the study population.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Photobiomodulation for Concussions: the Use of the ImPACT® Test as an Assessment Tool
Official Title Photobiomodulation for Concussions: the Use of the ImPACT® Test to Assess Improvement in Cognition and Symptomatology
Brief Summary Brain photobiomodulation (PBM) therapy is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders. Our emphasis on this study is to review the use of PBM as a treatment modality for concussions and the use of ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) test to assess improvement in cognition and symptomatology in patients with post-concussion syndrome (PCS) treated with PBM.
Detailed Description
  • This will be a retrospective, single arm, unmasked, clinical study.
  • Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment.
  • Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine.
  • Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test.
  • Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Data will be collected for all patients diagnosed with post-concussion syndrome who sought consult and treated using photobiomodulation therapy at Meditech Rehabilitation Centre using the BIOFLEX® DUO+ system
Condition Mild Traumatic Brain Injury
Intervention Device: BIOFLEX DUO+
  • Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment.
  • Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine.
  • Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test.
  • Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared.
Other Name: ImPACT test
Study Groups/Cohorts Concussion patients treated with Photobiomodulation
  • Patients between the ages of 15-65 years clinically diagnosed with a mild Traumatic Brain Injury by a health professional and currently not undergoing any treatment during a 1 year period from January 2018 to December 2018.
  • Documentation of the history of a qualifying mild Traumatic Brain Injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4.
Intervention: Device: BIOFLEX DUO+
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2021)
35
Original Actual Enrollment Same as current
Actual Study Completion Date March 29, 2021
Actual Primary Completion Date March 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients between the ages of 15-65 years clinically diagnosed with a mild Traumatic Brain Injury by a health professional and currently not undergoing any treatment during a 1 year period from January 2018 to December 2018.
  • Documentation of the history of a qualifying mild Traumatic Brain Injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4.

Exclusion Criteria:

  • Any positive findings on imaging studies
  • A diagnosis of or a family history of neuropsychiatric co-morbidity.
  • Any additional diagnoses compounding the diagnosis of a concussion or mild traumatic brain injury (TBI)
  • Currently undergoing any type of therapy
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04823507
Other Study ID Numbers BFX1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Only overall outcomes will be shared.
Current Responsible Party Meditech Rehabilitation Centre
Original Responsible Party Same as current
Current Study Sponsor Meditech Rehabilitation Centre
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Michael Zitney, MD Meditech Rehabilitation Centre
PRS Account Meditech Rehabilitation Centre
Verification Date March 2021