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LED Treatment to Improve Cognition and Promote Recovery in TBI (LED-TBI)

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ClinicalTrials.gov Identifier: NCT02404402
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Posttraumatic Stress Disorder Other: LED Other: sham LED Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : October 30, 2020

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




Primary Outcome Measures :
  1. Cognitive Functioning_Attention/Executive [ Time Frame: Eight Weeks ]
    Stroop Test ("Color-Word" test; Delis, Kaplan & Kramer, 2001)

  2. Cognitive Functioning_Learning/Memory [ Time Frame: Eight weeks ]
    California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)


Secondary Outcome Measures :
  1. Neuropsychiatric Status/Mood [ Time Frame: Eight weeks ]
    Beck Depression inventory (BDI; Beck, 2006)

  2. Neuropsychiatric status/PTSD [ Time Frame: Eight weeks ]
    PTSD Checklist - Military Version (PCL-M)

  3. Neuropsychiatric status/Sleep [ Time Frame: Eight weeks ]
    Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404402


Contacts
Contact: Yelena Bogdanova, PhD PhD (857) 364-2249 Yelena.Bogdanova@va.gov
Contact: Vivian Ho, BS (857) 364-4001 vivianho@bu.edu

Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Yelena Bogdanova, PhD PhD    857-364-2249    Yelena.Bogdanova@va.gov   
Contact: Vivian Ho, BS    (857) 364-4001    vivianho@bu.edu   
Principal Investigator: Yelena Bogdanova, PhD PhD         
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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02404402     History of Changes
Other Study ID Numbers: N1773-P
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders