LED Treatment to Improve Cognition and Promote Recovery in TBI (LED-TBI)

October 18, 2023 updated by: VA Office of Research and Development

Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130-4817
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active LED
Active LED Treatment
Other: LED
Low Level Light Therapy
Sham Comparator: Sham LED
Inactive (sham) LED Treatment
Other: sham LED
Inactive (sham) LED treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Functioning_Attention/Executive
Time Frame: Eight Weeks
Stroop Test ("Color-Word" test; Delis, Kaplan & Kramer, 2001)
Eight Weeks
Cognitive Functioning_Learning/Memory
Time Frame: Eight weeks
California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)
Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Status/Mood
Time Frame: Eight weeks
Beck Depression inventory (BDI; Beck, 2006)
Eight weeks
Neuropsychiatric status/PTSD
Time Frame: Eight weeks
PTSD Checklist - Military Version (PCL-M)
Eight weeks
Neuropsychiatric status/Sleep
Time Frame: Eight weeks
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Yelena Bogdanova, PhD PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimated)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N1773-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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