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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06239818
Status
Recruiting
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Conditions

  • Sports-related Concussion

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Photobiomodulation therapy (PBMt) — DEVICE
    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 — OTHER
    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.

Study Details

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

Key Dates

Start date
Apr 17, 2024
Status verified
Jul 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment: Photobiomodulation therapy (PBMt)
  • Active Comparator: Control

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Summer Ott, PsyD
[email protected]
(713) 486-3435

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