LED Treatment to Improve Cognition and Promote Recovery i... | NCT02404402

Studies
LED Treatment to Improve Cognition and Promote Recovery in TBI

NCT02404402

Sponsor

VA Office of Research and Development

Status

Completed

Last Update Posted

Apr 15, 2026Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Traumatic Brain Injury
Posttraumatic Stress Disorder

Interventions

LED
sham LED

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2015Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Feb 25, 2015

First Submission Date that Met QC Criteria

Mar 25, 2015

First Posted Date

Mar 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active LED	Experimental	Active LED Treatment	Other: LED
Sham LED	Sham Comparator	Inactive (sham) LED Treatment	Other: sham LED

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LED	Other	Low Level Light Therapy	Active LED
sham LED

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Neuropsychiatric Status/Mood	Beck Depression inventory (BDI; Beck, 2006)	Eight weeks
Neuropsychiatric status/PTSD	PTSD Checklist - Military Version (PCL-M)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yelena Bogdanova, PhD PhD	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA		Boston	Massachusetts	02130-4817	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28001756	Result	Naeser MA, Martin PI, Ho MD, Krengel MH, Bogdanova Y, Knight JA, Yee MK, Zafonte R, Frazier J, Hamblin MR, Koo BB. Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. Photomed Laser Surg. 2016 Dec;34(12):610-626. doi: 10.1089/pho.2015.4037.

ID	Term
D000070642	Brain Injuries, Traumatic
D013313	Stress Disorders, Post-Traumatic

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases