LED Treatment to Improve Cognition and Promote Recovery in TBI
LED-TBI
Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI
1 other identifier
interventional
8
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedApril 15, 2026
April 1, 2026
10.2 years
February 25, 2015
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (3)
Neuropsychiatric Status/Mood
Eight weeks
Neuropsychiatric status/PTSD
Eight weeks
Neuropsychiatric status/Sleep
Eight weeks
Study Arms (2)
Active LED
EXPERIMENTALActive LED Treatment
Sham LED
SHAM COMPARATORInactive (sham) LED Treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to TBI
- Hearing or vision impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817, United States
Related Publications (1)
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.
PMID: 28001756RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yelena Bogdanova, PhD PhD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 31, 2015
Study Start
May 1, 2015
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share