Recruiting

Photobiomodulation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06239818

Conditions

Sports-related Concussion

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Photobiomodulation therapy (PBMt)

Standard of Care

Study Details

Brief 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

Conditions

Sports-related Concussion

Study ID

NCT06239818

Start date

Apr 17, 2024

Status verified date

Jul, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment: Photobiomodulation therapy (PBMt)

active comparator: Control

Interventions

Photobiomodulation therapy (PBMt)

Participants 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

The 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.

Primary outcome measure

  • Change in depression as assessed by the Neuro-QoL Short Form v1.1 - Pediatric Depression scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (3-7 days post injury), Visit 3 (30 days post injury) ]
  • Change in Fractional Anisotropy (FA) of compact white matter as assessed by MRI of the brain [ Time Frame: Baseline (3-7 days post injury), Visit 3 (30 days post injury) ]
  • Change in Radial Diffusivity (RD) of compact white matter as assessed by MRI of the brain [ Time Frame: Baseline (3-7 days post injury), Visit 3 (30 days post injury) ]

Central Contacts and Locations

Central contacts

Summer Ott, PsyD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Summer Ott, PsyD

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-07-20.