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

Primary Purpose

Traumatic Brain Injury, Posttraumatic Stress Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LED
sham LED
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Light Emitting Diodes, Cognition, Neuromodulation, PTSD, Neurorehabilitation, Veterans, Sleep

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active LED

Sham LED

Arm Description

Active LED Treatment

Inactive (sham) LED Treatment

Outcomes

Primary Outcome Measures

Cognitive Functioning_Attention/Executive
Stroop Test ("Color-Word" test; Delis, Kaplan & Kramer, 2001)
Cognitive Functioning_Learning/Memory
California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)

Secondary Outcome Measures

Neuropsychiatric Status/Mood
Beck Depression inventory (BDI; Beck, 2006)
Neuropsychiatric status/PTSD
PTSD Checklist - Military Version (PCL-M)
Neuropsychiatric status/Sleep
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)

Full Information

First Posted
February 25, 2015
Last Updated
October 18, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02404402
Brief Title
LED Treatment to Improve Cognition and Promote Recovery in TBI
Acronym
LED-TBI
Official Title
Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Posttraumatic Stress Disorder
Keywords
Traumatic Brain Injury, Light Emitting Diodes, Cognition, Neuromodulation, PTSD, Neurorehabilitation, Veterans, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active LED
Arm Type
Experimental
Arm Description
Active LED Treatment
Arm Title
Sham LED
Arm Type
Sham Comparator
Arm Description
Inactive (sham) LED Treatment
Intervention Type
Other
Intervention Name(s)
LED
Intervention Description
Low Level Light Therapy
Intervention Type
Other
Intervention Name(s)
sham LED
Intervention Description
Inactive (sham) LED treatment
Primary Outcome Measure Information:
Title
Cognitive Functioning_Attention/Executive
Description
Stroop Test ("Color-Word" test; Delis, Kaplan & Kramer, 2001)
Time Frame
Eight Weeks
Title
Cognitive Functioning_Learning/Memory
Description
California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Neuropsychiatric Status/Mood
Description
Beck Depression inventory (BDI; Beck, 2006)
Time Frame
Eight weeks
Title
Neuropsychiatric status/PTSD
Description
PTSD Checklist - Military Version (PCL-M)
Time Frame
Eight weeks
Title
Neuropsychiatric status/Sleep
Description
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelena Bogdanova, PhD PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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LED Treatment to Improve Cognition and Promote Recovery in TBI

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