Photobiomodulation Therapy for Sports Concussion

N/A

Recruiting

Led By Summer Ott, PsyD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Concomitant extracranial injury worse than mild

Individuals who are taking benzodiazepines, anti-convulsants, mood stabilizers, stimulants, opioids, sleep aids, or other neuropsychiatric medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (3-7 days post injury), visit 2 (10-14 days post injury), visit 3 (30 days post injury)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the effects of Photobiomodulation therapy (PBMt) to the standard care for adolescent athletes who are at risk for delayed recovery from sports-related concussions. They

Who is the study for?

This trial is for adolescent athletes who are experiencing a slow recovery from recent sports-related concussions. Participants must be in the subacute phase of concussion, meaning they're past the initial injury but still have symptoms. They should not yet have received any other treatment for their concussion.

What is being tested?

The study is testing Photobiomodulation therapy (PBMt), which uses light to promote healing, against the standard care given for concussions. The goal is to see if PBMt can speed up recovery. Researchers will also use advanced MRI scans to look at how the brain's connections change over time with this treatment.

What are the potential side effects?

Since PBMt involves using light therapy, potential side effects may include discomfort or irritation at the site of application, headache, fatigue or dizziness post-treatment. However, these tend to be mild and temporary.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious injury in addition to my brain injury.

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I am currently taking medication for my mood, sleep, or seizures.

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I have undergone neurosurgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (3-7 days post injury), visit 2 (10-14 days post injury), visit 3 (30 days post injury)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (3-7 days post injury), visit 2 (10-14 days post injury), visit 3 (30 days post injury)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (3-7 days post injury), visit 2 (10-14 days post injury), visit 3 (30 days post injury) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+1 more

Secondary study objectives

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

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

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

+5 more