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

NCT06239818 | Recruiting FDA Device

• 1 other identifier: HSC-MS-23-0871
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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

  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.

  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)

  The Total Sleep Quality Score will be reported, and it ranges from 1 to 6. A higher score indicates better sleep quality.

  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

  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

  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

  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

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

Secondary Outcomes (8)

• Change in cognitive function as assessed by composite score on the Verbal Memory component of the ImPACT Concussion Test

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

• Change in cognitive function as assessed by composite score on the Visual Memory component of the ImPACT Concussion Test

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

• Change in cognitive function as assessed by composite score on the Visual Motor Speed component of the ImPACT Concussion Test

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

• Change in cognitive function as assessed by composite score on the Reaction Time component of the ImPACT Concussion Test

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

• Change in cognitive function as assessed by composite score on the Impulse Control component of the ImPACT Concussion Test

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

Study Arms (2)

Treatment: Photobiomodulation therapy (PBMt)

EXPERIMENTAL

Device: Photobiomodulation therapy (PBMt); Other: Standard of Care

Control

ACTIVE COMPARATOR

Other: Standard of Care

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.

Treatment: Photobiomodulation therapy (PBMt)

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.

Control; Treatment: Photobiomodulation therapy (PBMt)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• TIRR/Mission Connect: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Low-Level Light Therapy; Standard of Care

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Summer Ott, PsyD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Summer Ott, PsyD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 2, 2024
• Study Start: April 17, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)