What side effects are associated with this type of intervention?

Photobiomodulation therapy, including the use of Light Emitting Diodes (LED), is generally considered safe with minimal side effects. Some reported side effects include mild headaches, eye strain, and temporary dizziness. Other common treatments for TBI, such as medication (e.g., pain relievers, anti-seizure drugs), may have side effects like drowsiness, dizziness, gastrointestinal issues, and potential dependency. Rehabilitation therapies (physical, occupational, and speech therapy) are typically safe but can sometimes lead to temporary fatigue or muscle soreness.

What prior FDA approvals exist?

The provided context does not mention any specific FDA approvals for treatments related to Traumatic Brain Injury (TBI) using Light Emitting Diodes (LED) or Photobiomodulation. The context does discuss a study investigating the efficacy of LED treatment on cognition, neuropsychiatric status, and quality of life in individuals with TBI, but it does not provide details on FDA approvals or related drugs. Therefore, it is not possible to provide a summary of prior FDA approvals for such treatments based on the given information.

What other types of research exist?

Promising novel alternatives to Light Emitting Diodes (Photobiomodulation) for Traumatic Brain Injury patients include: 1) Mesenchymal stem cells induced to secrete high levels of neurotrophic factors, which have shown neuroprotective effects in clinical trials. 2) Ultra-high-dose methylcobalamin (vitamin B12), which has demonstrated neuroprotective effects in animal models and early-stage clinical trials. 3) Pharmacogenetic approaches that tailor treatments based on individual genetic profiles to enhance drug efficacy and safety.

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LED Therapy for Traumatic Brain Injury (LED-TBI Trial)

N/A

Waitlist Available

Led By Yelena Bogdanova, PhD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Age: 21-55

Be between 18 and 65 years old

Must not have

History of previous neurological diagnosis

Hearing or vision impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eight weeks

Summary

This trial tests if special lights can help people with brain injuries by making their brain cells work better. It aims to improve memory, sleep, and overall quality of life. Previous research has shown that using these lights after a brain injury can protect brain cells.

Who is the study for?

This trial is for English-speaking adults aged 21-55 who have experienced a mild traumatic brain injury (TBI) with loss of consciousness for no more than 30 minutes. It's specifically aimed at active-duty personnel or veterans exposed to blasts. People with penetrating head injuries, previous neurological or psychotic disorders, or significant hearing or vision impairments cannot participate.

What is being tested?

The study is testing the effectiveness of light emitting diodes (LED) therapy compared to a fake LED treatment (sham) in improving cognitive function and quality of life for those with TBI. Participants will be randomly assigned to receive either the real LED treatment or sham.

What are the potential side effects?

Since this trial involves LED therapy, side effects are expected to be minimal but may include discomfort at the site of application, headache, eye strain, or other light-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 55 years old.

Exclusion Criteria

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

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I have a history of neurological conditions.

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I have difficulty with my hearing or vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ eight weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~eight weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and eight weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cognitive Functioning_Attention/Executive

Cognitive Functioning_Learning/Memory

Secondary study objectives

Neuropsychiatric Status/Mood

Neuropsychiatric status/PTSD

Neuropsychiatric status/Sleep

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active LEDExperimental Treatment1 Intervention

Active LED Treatment

Group II: Sham LEDPlacebo Group1 Intervention

Inactive (sham) LED Treatment

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Photobiomodulation, particularly using Light Emitting Diodes (LED), is a promising treatment for Traumatic Brain Injury (TBI). The mechanism of action involves the application of specific wavelengths of light to the scalp, which penetrates the skull and is absorbed by brain tissues. This light energy is believed to enhance cellular function by stimulating mitochondrial activity, leading to increased ATP production, reduced oxidative stress, and modulation of inflammatory processes. These effects can promote neuroprotection, reduce neuronal damage, and support cognitive recovery. For TBI patients, these mechanisms are crucial as they address the underlying cellular dysfunction and inflammation that contribute to the symptoms and long-term consequences of brain injury.

Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial.