The purpose of this study is to compare effects of Photobiomodulation therapy (PBMt) to standard of care in adolescent athletes at risk for delayed recovery from subacute sports concussion, to substantiate the impact of subacute PBMt over time on functional and structural connectivity of the brain using advanced MRI sequences and to correlate the psychological and behavioral outcomes to neuroimaging findings
current participants in a school- or club-sponsored sport (contact or non-contact)
access to wireless internet service at home
diagnosis of sports-related concussion (SRC) (according to consensus diagnostic criteria) by a licensed healthcare provider,3-7 days from the concussive injury at the time of enrolment
considered at-risk for protracted recovery based on Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) performance and symptom reporting on the Post-Concussion Symptom Scale (PCSS)
acute neurologic deterioration to a Glasgow Coma Scale score less than 13
neurosurgical intervention
abnormal CT scan
concomitant extracranial injury worse than mild
Parallel
Photobiomodulation therapy (PBMt)
DeviceParticipants will be asked to use the photobiomodulation (PBM) device for 20 minutes, daily (e.g., Monday - Sunday) for a total of 30 days. The device will be preprogrammed and automatically switched off after 20 minutes.
Standard of Care
Other interventionThe patient is provided with verbal and written education including what a mild traumatic brain injury (mTBI) is, favorable expectations for recovery, and advice about how to manage specific symptoms. Relative rest for the first 24-48 hours after an mTBI is recommended as the main goal is to alleviate symptoms and reduce demands on the brain. After an initial period of relative rest and symptom stabilization, patients are encouraged to gradually resume normal daily activities as tolerated. Physical and cognitive activities can be progressively resumed at a pace that does not worse existing or create new symptoms. Education, return to activity advice, and symptom management are all reviewed in subsequent visits as needed.
Change in depression as assessed by the Neuro-QoL Short Form v1.1 - Pediatric Depression scale
This is an 8 item questionnaire, and each item is scored on a 5 point Likert scale from 1 (never) to 5 (almost always), for a total score range of 8 to 40 and with a higher score indicating a worse outcome.
Change in anxiety as assessed by the Neuro-QoL Short Form v1.0 - Pediatric Anxiety scale
This is an 8 item questionnaire, and each item is scored on a 5 point Likert scale from 1 (never) to 5 (almost always), for a total score range of 8 to 40 and with a higher score indicating a worse outcome.
Change in intensity of post-concussion symptoms as assessed by Total Symptom Score on the Post-Concussion Symptoms Scale (PCSS) of the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Concussion Test
The PCSS of the ImPACT Concussion Test consists of a list of 22 symptoms for which participants rate the intensity of a symptom from 0 (none) to 6 (severe), for a Total Symptom Score range of 0 to 132 and with a higher score indicating a higher symptom total.
Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version)
The Total Sleep Quality Score will be reported, and it ranges from 1 to 6. A higher score indicates better sleep quality.
Change in cognitive function as assessed by composite score on the Verbal Memory component of the ImPACT Concussion Test
Composite score on the Verbal Memory component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 100, with a higher score indicating a better outcome.
Change in cognitive function as assessed by composite score on the Visual Memory component of the ImPACT Concussion Test
Composite score on the Visual Memory component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 100, with a higher score indicating a better outcome.
Change in cognitive function as assessed by composite score on the Visual Motor Speed component of the ImPACT Concussion Test
Composite score on the Visual Motor Speed component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 50, with a higher score indicating a better outcome.
Change in cognitive function as assessed by composite score on the Reaction Time component of the ImPACT Concussion Test
Composite score on the Reaction Time component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 1.50, with a lower time indicating a better outcome.
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The University of Texas Health Science Center, Houston
Lead sponsor
TIRR/Mission Connect
Collaborator
