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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
Awards & highlights

Summary

This trial tests if a new brain injury treatment using light emitting diodes (LED) is effective in improving cognition, mental health, and quality of life.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive Functioning_Attention/Executive
Cognitive Functioning_Learning/Memory
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,971 Total Patients Enrolled
Yelena Bogdanova, PhD PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
77 Total Patients Enrolled

Media Library

LED (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02404402 — N/A
Traumatic Brain Injury Research Study Groups: Active LED, Sham LED
Traumatic Brain Injury Clinical Trial 2023: LED Highlights & Side Effects. Trial Name: NCT02404402 — N/A
LED (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02404402 — N/A
~1 spots leftby Oct 2025