RecruitingNot Applicable

Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents

United States30 participantsStarted 2024-04-17

Plain-language summary

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

Who can participate

Age range13 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * acute neurologic deterioration to a Glasgow Coma Scale score less than 13 * neurosurgical intervention * abnormal CT scan * concomitant extracranial injury worse than mild * pre-injury conditions which confound effects of SRC (e.g., epilepsy, schizophrenia, bipolar illness, mental deficiency, hospitalization for TBI) * substance dependence * inability to speak fluent English * Individuals who are taking benzodiazepines, anti-convulsants, mood stabilizers, stimulants, opioids, sleep aids, or other neuropsychiatric medications

What they're measuring

Change in depression as assessed by the Neuro-QoL Short Form v1.1 - Pediatric Depression scale

Timeframe: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)

Change in anxiety as assessed by the Neuro-QoL Short Form v1.0 - Pediatric Anxiety scale

Timeframe: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)

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

Timeframe: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)

Change in quality of sleep as assessed by the Adolescent Sleep-Wake Scale-S (ASWS-Short Version)

Timeframe: Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)

Change in brain volume as assessed by Magnetic Resonance Imaging (MRI) of the brain

Timeframe: Baseline (3-7 days post injury), Visit 3 (30 days post injury)

Change in Diffusion Tensor Image Analysis Along the Perivascular Space (DTI-ALPS) as assessed by MRI of the brain

Timeframe: Baseline (3-7 days post injury), Visit 3 (30 days post injury)

Trial details

NCT IDNCT06239818

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Summer Ott, PsyD

(713) 486-3435 Summer.D.Ott@uth.tmc.edu

View on ClinicalTrials.gov More Sports-related Concussion trials