LED Treatment to Improve Cognition and Promote Recovery in TBI

Not Applicable

Active, not recruiting

• Conditions: Posttraumatic Stress Disorder; Traumatic Brain Injury

• Registration Number: NCT02404402
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-31
• Study Start: 2015-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States