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

Completed

• Conditions: Mild Traumatic Brain Injury
• Interventions: Device: BIOFLEX DUO+

• Registration Number: NCT04823507
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-26
• Primary Completion: 2021-03-29
• Study Completion: 2021-03-29
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-03-30
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Concussion patients treated with Photobiomodulation	BIOFLEX DUO+	* 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.

Primary Outcome Measures

Name	Time	Method
Improvement in ImPACT test scores after treatment with Photobiomodulation.	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.

Trial Locations

Locations (1)

Meditech Rehabilitation Centre; 🇨🇦 Toronto, Ontario, Canada