Scalp Application of Red and Near-Infrared Light, From Light-Emitting Diodes (LED) to Improve Thinking and Memory in Veterans With Gulf War Illnesses (LED Treat GWVI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01782378
First received: January 30, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to learn if an experimental treatment can help thinking ability, and memory in Veterans with Gulf War Veterans Illnesses (GWVI). The experimental treatment is called transcranial, light-emitting diodes (LEDs), that are applied outside the skull, to the head. The LEDs are applied to three sets of placements on the head. Each placement set is treated for 6 and a half minutes. 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 red and 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
Persian Gulf Syndrome
Neurobehavioral Manifestations
Memory Disorders
Device: Photomedex Helmet, with Red/Near-Infrared Light-Emitting Diodes (LEDs)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial, Light-Emitting Diode (LED) Therapy to Improve Cognition in GWVI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Attention/Executive Function [ Time Frame: 1 Week after the last LED treatment in each treatment series ] [ Designated as safety issue: No ]
    Stroop Test ("Color-Word" test) (Delis, Kaplan & Kramer, 2001)


Secondary Outcome Measures:
  • Additional Attention/Executive Function [ Time Frame: 1 Week after the last LED treatment in each treatment series ] [ Designated as safety issue: No ]
    Digit Span Subtests (WAIS-IV; Wechsler, 2008) D-KEF Trails (Delis, Kaplan & Kramer, 2001)

  • Learning and Memory [ Time Frame: 1 Week after the last LED treatment in each treatment series ] [ Designated as safety issue: No ]
    California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)

  • Mood [ Time Frame: 2 Months after the last LED treatment ] [ Designated as safety issue: No ]
    Beck Depression inventory (BDI; Beck, 2006)

  • Data for General Physical Health [ Time Frame: 2 Months after the last LED treatment ] [ Designated as safety issue: No ]
    Short Form-36V Plus (Ware et al., 2000) Health Symptom Checklist (HSC). 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).

  • Blood Tests [ Time Frame: Within 1 Week of the last LED treatment ] [ Designated as safety issue: No ]
    Tests for Mitochondrial Function Tests for Inflammation Tests for Coagulation Tests for General Health


Estimated Enrollment: 160
Study Start Date: May 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real LED Treatment Series First
Participants in this group first receive a series of 15 real LED treatments with the helmet containing the real LEDs. At 1 week following the last real LED treatment, these participants then receive a series of 15 sham LED treatments with the helmet containing the sham LEDs.
Device: Photomedex Helmet, with Red/Near-Infrared Light-Emitting Diodes (LEDs)

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 First
Participants in this group first receive a series of 15 sham LED treatments with the helmet containing the sham LEDs. At 1 week following the last sham LED treatment, these participants then receive a series of 15 real LED treatments with the helmet containing the real LEDs.
Device: Photomedex Helmet, with Red/Near-Infrared Light-Emitting Diodes (LEDs)

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:   38 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The participants for this study will be recruited from the participants in a Department of Defense (DoD) study of a longitudinal cohort of Gulf War Veterans who returned from their deployment in 1991 through Ft. Devens, MA. This cohort has been followed at multiple time points since the end of war.

Participants will have answered 'Yes' to the following questions completed on the cohort survey: 1) Difficulty concentrating; and/or 2) Difficulty remembering recent information.

  • Must be a veteran deployed in 1990-1991 Gulf War
  • Meets criteria for GWVI as defined by "Symptom Questions used to identify Gulf War Illness by Kansas Case Definition, and Chronic Multisymptom Illness by Fukuda Case Definition" (Steele, 2000; Fukuda et al., 1998). Participants must have the presence of 1 or more chronic symptoms (lasting >6 months) from at least 2 of 3 symptom categories from Fukuda et al., (1998): 1) musculoskeletal (muscle pain, or joint pain, stiffness); 2) mood-cognition 3) fatigue.
  • Ages 38 - 65 years
  • 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

Exclusion Criteria:

  • Not meeting criteria for GWVI as defined by Symptom Questions used to identify Gulf War Illness by Kansas Case Definition, and Chronic Multisymptom Illness by Fukuda Case Definition" (Steele, 2000; Fukuda et al., 1998).
  • Had 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 38, or greater than age 65
  • Presence of a neurodegenerative disease such as 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 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: NCT01782378

Locations
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: Margaret Naeser, PhD VA Medical Center, Jamaica Plain Campus
Principal Investigator: Michael D. Ho, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01782378     History of Changes
Other Study ID Numbers: SPLD-014-12S, 1I01CX000524-01A1
Study First Received: January 30, 2013
Last Updated: July 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Persian Gulf Syndrome
Veterans Health
Executive Function
Memory
Attention
Cognition
Laser Therapy, Low-Level
Phototherapy
Light Therapy
Depression

Additional relevant MeSH terms:
Memory Disorders
Persian Gulf Syndrome
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Occupational Diseases

ClinicalTrials.gov processed this record on August 01, 2014