LED-TBI: LED Treatment to Improve Cognition and Promote Recovery in TBI

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02404402
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 108
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury; Posttraumatic Stress Disorder	Other: LED; Other: sham LED	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI
• Actual Study Start Date: May 1, 2015
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active LED Active LED Treatment	Other: LED; Low Level Light Therapy
Sham Comparator: Sham LED Inactive (sham) LED Treatment	Other: sham LED; Inactive (sham) LED treatment

Outcome Measures

Primary Outcome Measures

1. Cognitive Functioning_Attention/Executive [Eight Weeks]

   Stroop Test ("Color-Word" test; Delis, Kaplan & Kramer, 2001)

2. Cognitive Functioning_Learning/Memory [Eight weeks]

   California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)

Secondary Outcome Measures

1. Neuropsychiatric Status/Mood [Eight weeks]

   Beck Depression inventory (BDI; Beck, 2006)

2. Neuropsychiatric status/PTSD [Eight weeks]

   PTSD Checklist - Military Version (PCL-M)

3. Neuropsychiatric status/Sleep [Eight weeks]

   Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Yelena Bogdanova, PhD PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02404402
• Other Study ID Numbers: N1773-P
• First Posted: Mar 31, 2015
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by VA Office of Research and Development: Traumatic Brain Injury; Light Emitting Diodes; Cognition; Neuromodulation; PTSD; Neurorehabilitation; Veterans; Sleep
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Dec 29, 2021