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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02404402
First received: February 25, 2015
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Traumatic Brain Injury
Posttraumatic Stress Disorder
Other: LED
Other: sham LED
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI

Further study details as provided by VA Office of Research and Development:

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

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


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

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

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


Estimated Enrollment: 32
Actual Study Start Date: May 1, 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02404402     History of Changes
Other Study ID Numbers: N1773-P
Study First Received: February 25, 2015
Last Updated: January 25, 2017
Individual Participant Data  
Plan to Share IPD: 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
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

ClinicalTrials.gov processed this record on March 22, 2017