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LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans

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:
NCT02356861
First received: February 2, 2015
Last updated: January 11, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to learn if an experimental treatment can help thinking ability, and memory in Veterans with mild or moderate traumatic brain injury (mTBI), and post-traumatic stress disorder (PTSD). The experimental treatment is called transcranial, light-emitting diode (LEDs) therapy,and uses groups of LEDs mounted inside a helmet. The helmet is worn on the head, and the LEDs shine painless light on the sides, middle and front of the head through the scalp. The participants receive a series of LED treatments which take place as outpatient visits at the VA Boston Healthcare System, Jamaica Plain Campus. The LEDs contain near-infrared diodes. The FDA considers the LED device used here, to be a non-significant risk device. The LEDs do not produce heat.

Condition Intervention Phase
Traumatic Brain Injury (TBI)
Post-traumatic Stress Disorder (PTSD)
Device: Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: LED Light Therapy to Improve Cognitive/Psychosocial Function in TBI-PTSD Veterans

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

Primary Outcome Measures:
  • Stroop Test ("Color-Word" test) (Delis, Kaplan & Kramer, 2001) [ Time Frame: 1 Week after the last LED treatment in each treatment series ]
    Attention/Executive Function


Secondary Outcome Measures:
  • Digit Span Subtests (WAIS-IV; Wechsler, 2008) D-KEF Trails (Delis, Kaplan & Kramer, 2001) [ Time Frame: 1 Week after the last LED treatment in each treatment series ]
    Additional Attention/Executive Function

  • California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000) [ Time Frame: 1 Week after the last LED treatment in each treatment series ]
    Learning and Memory

  • Beck Depression inventory (BDI; Beck, 2006) [ Time Frame: 2 Months after the last LED treatment ]
    Mood [ Time Frame:

  • hort Form-36V Plus (Ware et al., 2000) Health Symptom Checklist (HSC). [ Time Frame: 2 Months after the last LED treatment ]
    Data for General Physical Health. The HSC is a comprehensive list of 34 frequently reported health and mental health symptoms originally adapted from Bartone et al., (1989). It asks how often in the past 30 days each of the health symptoms was experienced. Symptoms from nine body systems are assessed (cardiac, pulmonary, dermatological, gastrointestinal, genitourinary, musculoskeletal, neurological, and psychological).


Estimated Enrollment: 50
Study Start Date: March 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real, Active LED Treatment Series
These participants will first receive a series of 12, sham LED treatments, At 1 week post completion of the Sham LED treatment series, participants in this group receive a series of 12 real LED treatments from the helmet housing LEDs that deliver photons of light in the infrared range.
Device: Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on

The LED helmet from Photomedex, Montgomeryville, PA will be used.

18 LED pods are in the helmet. Each LED pod:

Pod size: 19 cm2 Power output: 692.5 mW Power density: 36.5 mW/cm2

20 NIR diodes, 830 nm and 4 red diodes, 633 nm.

1 J/cm2 = 30.4 sec

Sham Comparator: Sham LED Treatment Series
These participants will first receive an initial series of 12 sham LED treatments from the helmet containing the sham LEDs.
Device: Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on

The LED helmet from Photomedex, Montgomeryville, PA will be used.

18 LED pods are in the helmet. Each LED pod:

Pod size: 19 cm2 Power output: 692.5 mW Power density: 36.5 mW/cm2

20 NIR diodes, 830 nm and 4 red diodes, 633 nm.

1 J/cm2 = 30.4 sec


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria:

The participants for this study will be recruited from flyers posted within the VA Boston Healthcare System and Veterans who contact the study after hearing about it from an outside referral source who knows that the study is actively recruiting participants. Participants must have both mild or moderate TBI and PTSD

  • Males or Females; Ages 18 - 60 years old
  • Must be physically able to travel to the VA Boston Healthcare System, Jamaica Plain, for Neuropsychological testing and transcranial LED treatments
  • Must meet screening criteria from the Neuropsychological Screening Tests
  • Must meet screening criteria fro a PTSD diagnosis

Exclusion Criteria:

Exclusion Criteria:

  • Not meeting criteria for post-traumatic stress disorder and for mild or moderate traumatic brain injury
  • Had Gulf War Veterans' Illnesses (GWVI), but did not answer 'Yes' to the following questions: 1) Difficulty concentrating and/or 2) Difficulty remembering recent information, on the Symptom Questionnaire
  • Less than age 18, or greater than age 60
  • Presence of a neurodegenerative disease such as Amyotrophic Lateral Sclerosis (ALS), Parkinson's, Dementia
  • Presence of a life-threatening disease such as cancer
  • Presence of a severe mental disorder such as schizophrenia, or severe depression
  • Physical limitations that would prevent traveling to the VA Boston Healthcare System, Jamaica Plain, for Neuropsychological testing and transcranial LED treatments
  • Current substance abuse or in active treatment
  • Did not meet screening criteria from the Neuropsychological Screening Tests
  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: NCT02356861

Contacts
Contact: Jeffrey A Knight, PhD (857) 364-4133 jeffrey.knight@va.gov
Contact: Margaret Naeser, PhD Margaret.Naeser@va.gov

Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Maria Higgins    857-364-4802    maria.higgins@va.gov   
Contact: Donna Kantarges    (617) 323-7700 ext 5151    donna.kantarges@va.gov   
Principal Investigator: Jeffrey A Knight, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jeffrey A Knight, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02356861     History of Changes
Other Study ID Numbers: D1768-P
1I21RX001768-01 ( US NIH Grant/Contract Award Number )
Study First Received: February 2, 2015
Last Updated: January 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
treatment
photobiomodulation
Veterans
brain-injury
TBI
PTSD

Additional relevant MeSH terms:
Brain Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 26, 2017