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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

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.

Condition or disease Intervention/treatment
Mild Traumatic Brain Injury Device: BIOFLEX DUO+

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.

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Photobiomodulation for Concussions: the Use of the ImPACT® Test to Assess Improvement in Cognition and Symptomatology
Actual Study Start Date : March 26, 2021
Actual Primary Completion Date : March 29, 2021
Actual Study Completion Date : March 29, 2021

Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

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): NCT04823507


Locations
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Canada, Ontario
Meditech Rehabilitation Centre
Toronto, Ontario, Canada, M8W 4W3
Sponsors and Collaborators
Meditech Rehabilitation Centre
Investigators
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Principal Investigator: Michael Zitney, MD Meditech Rehabilitation Centre
Additional Information:
ICD 10  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Meditech Rehabilitation Centre
ClinicalTrials.gov Identifier: NCT04823507    
Other Study ID Numbers: BFX1
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only overall outcomes will be shared.

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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
Keywords provided by Meditech Rehabilitation Centre:
Concussion, Photobiomodulation, ImPACT
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating