LED Treatment to Improve Cognition and Promote Recovery in TBI

Traumatic Brain Injury Clinical Trial

— LED-TBI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02404402
• Other study ID #: N1773-P
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: October 31, 2026

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Traumatic Brain Injury

Intervention

Other:
• LED
Low Level Light Therapy
• sham LED
Inactive (sham) LED treatment

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Functioning_Attention/Executive	Stroop Test ("Color-Word" test; Delis, Kaplan & Kramer, 2001)	Eight Weeks
Primary	Cognitive Functioning_Learning/Memory	California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)	Eight weeks
Secondary	Neuropsychiatric Status/Mood	Beck Depression inventory (BDI; Beck, 2006)	Eight weeks
Secondary	Neuropsychiatric status/PTSD	PTSD Checklist - Military Version (PCL-M)	Eight weeks
Secondary	Neuropsychiatric status/Sleep	Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)	Eight weeks