Scalp Application of LED Therapy to Improve Thinking and Memory in Veterans With Gulf War Illness
Gulf War Veterans Illness · Neurobehavioral Manifestations · Memory Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01782378 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real LED Treatment (Device); Sham LED Treatment (Device)
- Age
- Adult, Older Adult · 38+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Digit Span Forwards |
8.7; 9.22; 8.33; 9.36; 9.11; 9.8 | <0.01 sig |
| PRIMARY Digit Span Backwards |
5.78; 6.39; 7.21; 7.73; 6.94; 7 | 0.88 |
| PRIMARY Digit Span Total Forward + Backwards |
14.48; 15.61; 15.54; 15.86; 16.06; 16.79 | 0.81 |
| PRIMARY Trails Condition 2 |
34.56; 39.61; 34.5; 37.59; 34; 33.26 | 0.23 |
| PRIMARY Trails Condition 4 |
87.72; 97.74; 88.83; 79.63; 80.61; 89.68 | <0.12 |
| PRIMARY Stroop Inhibition (Trial 3) |
60.8; 60.83; 59.54; 57.81; 56.33; 60.63 | <0.52 |
| PRIMARY Stroop Inhibition/Switching |
72.04; 68.22; 68.5; 62.46; 72.44; 59 | <0.27 |
| PRIMARY California Verbal Learning Test -II (CVLT-II) Total Trials 1-5 |
45.48; 41.09; 47.96; 46.05; 50; 50.42 | <0.37 |
| PRIMARY CVLT-II, Short Delay Free Recall |
9.52; 8.13; 10.38; 9.5; 10.9; 10.74 | <0.36 |
| PRIMARY CVLT-II, Short Delay Cued Recall |
11; 10.22; 12.04; 10.82; 12.56; 11.84 | <0.46 |
| PRIMARY CVLT-II Long Delay Free Recall |
10; 8.49; 11; 9.82; 11.4; 10.21 | <0.84 |
| PRIMARY CVLT-II Long Delay Cued Recall |
11; 9.83; 11.9; 10.96; 12.56; 11.48 | <0.93 |
| PRIMARY Conner's Continuous Performance Test II (CPT) False Alarms |
30.48; 24.14; 26.16; 18.32; 26.72; 17.22 | <0.85 |
| PRIMARY CPT Correct Detections, Reaction Time (RT) |
477.41; 464.62; 476.38; 470.82; 457.02; 467.5 | <0.26 |
| PRIMARY Conner's Continuous Performance Test II (CPT), D' |
1.84; -0.67; 0.499; -.836; 0.24; -1.13 | <0.45 |
| PRIMARY Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall |
16.16; 14.87; 20.56; 18.14; 22.22; 18.658 | <0.46 |
| PRIMARY ROCFT, Delayed Recall |
15.75; 14.28; 18.96; 17.5; 21.64; 19 | <0.64 |
| SECONDARY Beck Depression Inventory (BDI) |
19.72; 15.17; 18.91; 11.95; 17.06; 13.05 | <0.82 |
| SECONDARY PCL-Civilian Survey |
48.83; 40.30; 42.04; 35.43; 42.5; 36.32 | <0.43 |
| SECONDARY Visual Analog Pain Rating |
3.48; 3.59; 3.06; 2.73; 3.14; 2.4 | <0.15 |
| SECONDARY Short Form McGill Pain Questionnaire |
9.58; 10.74; 11.38; 9; 9.67; 8.63 | .08 |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
10.12; 8.39; 9.54; 7.64; 9.11; 7.05 | <0.7 |
| SECONDARY Karolinska Sleepiness Scale |
5.08; 4.35; 4.58; 4.27; 5.33; 3.53 | <0.48 |
| SECONDARY Short Form-36V Plus (PCS) |
-.85; -.83; -1.06; -.76; -.91; -.61 | <0.02 sig |
| SECONDARY Short Form-36V Plus (MCS) |
-.64; -.20; -.53; -.078; -.50; -.34 | <0.36 |
| SECONDARY Multidimensional Fatigue Inventory (MFI), General Score |
14.08; 11.83; 13.9; 12.68; 14.44; 11.74 | <0.82 |
| SECONDARY Multidimensional Fatigue Inventory, Physical Score |
11.32; 11.57; 11.5; 10.73; 11.83; 11 | <0.2 |
| SECONDARY Multidimensional Fatigue Inventory, Reduced Activity Score |
11.52; 10.48; 11.21; 11.05; 11.6; 9.47 | <0.71 |
| SECONDARY Multidimensional Fatigue Inventory, Reduced Motivation Activity |
10.44; 9.78; 10.67; 9.96; 11.28; 10.32 | <0.85 |
| SECONDARY Multidimensional Fatigue Inventory, Mental Fatigue |
14.24; 12.83; 13.71; 12.5; 13.72; 13.05 | <0.44 |
Summary
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
Data sourced from ClinicalTrials.gov (NCT01782378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.