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

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

Study Overview

• Status: Recruiting
• Conditions: Sports-related Concussion
• Intervention / Treatment: Device: Photobiomodulation therapy (PBMt); Other: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Summer Ott, PsyD; Phone Number: (713) 486-3435; Email: Summer.D.Ott@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Summer Ott, PsyD; Phone Number: (713) 486-3435; Email: Summer.D.Ott@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: 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.
Experimental: Treatment: Photobiomodulation therapy (PBMt)	Device: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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	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.	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	Composite score on the Impulse Control component of the ImPACT Concussion Test will be reported, and it ranges from 0 to 30, with a lower score indicating a better outcome.	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 the Neuro-QoL Short Form v2.0 - Pediatric Cognitive Function scale	This is an 8 item questionnaire, and each item is scored from 1 (very much) to 5 (not at all), for a total score range of 8 to 40 and with a higher score indicating a better outcome.	Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
Change in stress as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form v1.0 - Psychological Stress Experiences 8a scale	This is an 8 item questionnaire, and each item is scored from 1 (never) to 5 (always), for a total score range of 8 to 40 and with a higher score indicating more stress.	Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)
Change in quality of life as assessed by the PROMIS Pediatric Scale v1.0 - Global Health 7 scale	This is a 7 item questionnaire, and each item is score from 1 to 5, for a total score range of 7 to 35 and with a higher score indicating a better outcome.	Baseline (3-7 days post injury), Visit 2 (10-14 days post injury), Visit 3 (30 days post injury)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: TIRR/Mission Connect
• Investigators: Principal Investigator: Summer Ott, PsyD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-23-0871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No