LED Treatment to Improve Cognition and Promote Recovery in TBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Photobiomodulation to Improve Cognition in TBI, With fMRI

NCT04230577

Traumatic Brain Injury Closed Head Injury Cognitive Dysfunction

UNKNOWN EARLY_PHASE1

Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial

NCT02393079

Brain Injury Cognitive Deficits

COMPLETED NA

Effects of LEDs on Memory in TBI Patients

NCT01598532

Traumatic Brain Injury

COMPLETED NA

LED Therapy for the Treatment of Concussive Brain Injury

NCT02383472

Brain Concussion

COMPLETED NA

Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

NCT01138020

Traumatic Brain Injury Cognitive Symptoms

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Posttraumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active LED

Active LED Treatment

Group Type EXPERIMENTAL

LED

Intervention Type OTHER

Low Level Light Therapy

Sham LED

Inactive (sham) LED Treatment

Group Type SHAM_COMPARATOR

sham LED

Intervention Type OTHER

Inactive (sham) LED treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LED

Low Level Light Therapy

Intervention Type OTHER

sham LED

Inactive (sham) LED treatment

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure
* Meets criteria for mild TBI
* LOC of 30 min or less
* Age: 21-55
* Primary language is English

Exclusion Criteria

* Evidence of penetrating head injury
* History of previous neurological diagnosis
* History of previous psychotic disorder prior to TBI
* Hearing or vision impairment

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No