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

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.

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)

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.

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)

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.

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)

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.

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)

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

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)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.