Scalp Application of LED Therapy to Improve Thinking and Memory in Veterans With Gulf War Illness
Gulf War Veterans Illness, Neurobehavioral Manifestations, Memory Disorders
About this trial
This is an interventional treatment trial for Gulf War Veterans Illness focused on measuring Gulf War Veterans Illness, Veterans Health, Executive Function, Memory, Attention, Cognition, Laser Therapy, Low-Level, Phototherapy, Light Therapy, Depression, Light-Emitting Diodes
Eligibility Criteria
Inclusion Criteria:
Participants were 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 (Proctor et al., 1998), and through the VA Informatics and Computing Infrastructure (VINCI)/Corporate Data Warehouse (CDW) database, with approval from NDS. The San Francisco VA Medical Center (SF VAMC) was a second site on the study (35 Veterans were run in Boston; 12 were run in San Francisco on the same protocol.)
Those recruited from the VINCI/CDW database, resided within a 25 mile radius of the Boston VA Healthcare System (VABHS) or 25 miles of the SF VA Medical Center (VAMC). The Institutional Review Board at the VA BHS and the SF VAMC (University of California, San Francisco) approved the study. In accordance with the Declaration of Helsinki, Informed Consent and HIPAA authorization was obtained from all participants.
Participants answered 'Yes' to the following questions: 1) Difficulty concentrating; and/or 2) Difficulty remembering recent information.
- Must be a Veteran deployed in 1990-1991 Gulf War, in the Kuwait Theatre
- 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 or San Francisco VA Medical Center, for Neuropsychological testing and transcranial LED treatments
- Must meet screening criteria from the Eligibility Screening:
The following Neuropsychological (NP) tests were administered at Screening: Trail Making Test A & B (Reynolds, 2002); Controlled Oral Word Association Test (COWAT (FAS); Spreen & Benton, 1977; Benton and Hamsher, 1989); California Verbal Learning Test - II (Delis et al., 2000); Color-Word Interference Test (Stroop; Delis, Kaplan, Kramer, 2001). Additional screening tests included: Short Form McGill Pain Questionnaire (Melzac, 1984); Overall VAS current pain rating (0-10); and the PTSD Checklist- Civilian (PCL-C, Weathers et al., 1994).
Participants were required to score at least 2 SD below the standardized norm (age, education, gender) on at least 1 NP screening test or 1 SD below the standardized norm on at least 2 NP screening tests. The Word Reading Subtest from the Wide Range Achievement Test-4 (Wilkinson and Robertson, 2006) was used to estimate premorbid level of cognitive functioning. The SD for each participant on each NP screening test was adjusted by his/her estimated premorbid cognitive level.
The Test of Memory Malingering (TOMM, 1996) was administered. Participants who failed Trial 2, or Trial 1 and 2 were excluded from the study. If a participant failed Trial 1, but did not fail Trial 2, he/she was not excluded if he/she showed evidence of poor learning on other NP screening tests such as the CVLT (Schroeder et al., 2013, Arch Clin Neuropsych) Participants were required to have a level of pain 7/10 or less on the VAS and less than 38/50 on the McGill pain questionnaires at screening, as pain has been shown to influence cognition (Moriarty et al., 2011, Review).
Exclusion Criteria:
- 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 bipolar depression (not associated with PTSD)
- Current substance abuse or active treatment within last 6 months
Sites / Locations
- San Francisco VA Medical Center, San Francisco, CA
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Real LED Treatment Series
Sham LED Treatment Series
Participants in this group receive a series of 15 real LED treatments with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (633 nm, and 810 nm, Vielight, Inc., Toronto), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads (MedX Health, Toronto) were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and the person performing the treatment wore goggles that block red wavelength (from the red intranasal). Real or Sham LED devices look and feel identical.
Participants in this group first receive a series of 15 sham LED treatments with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial LED Helmet and two intranasal nose clips (sham LEDs, Vielight, Inc., Toronto), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two sham LED cluster heads (MedX Health, Toronto) were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and the person performing the treatment wore goggles that block red wavelength (from the red intranasal). Real or Sham LED devices look and feel identical.