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

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Stomatognathic Diseases Tooth Diseases Tooth, Impacted Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meditech Rehabilitation Centre

Toronto, Ontario, M8W 4W3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIOFLEX DUO+

Device

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 names: ImPACT test

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Meditech Rehabilitation Centre

Other

Registry information

Official study title

Photobiomodulation for Concussions: the Use of the ImPACT® Test to Assess Improvement in Cognition and Symptomatology

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Mar 30, 2021
Registry last updated: Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed