The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of Gulf War Illness. By using the literature of previous studies, the investigators have chosen to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and improve synaptic functioning in key areas of the brain.
Our study is a pilot study for the novel treatment of d-cycloserine to treat GWI. Our study will consist of two experimental groups of equal size (n=28): DCS treatment group and a placebo group. Participants will be randomized into either group; with a double blind study design. Participants will be instructed to self-administer their treatment pills once per day for 28 days. There will be a total of 6 study visits that will include medical and neuropsychological assessment. The first visit will be for establishing eligibility and baseline functioning. Three visits (visits 2-4) will occur during the medication trial (day 1, day 2 and two weeks into medication/placebo). Visit 5 will occur around the time medication/placebo is finished. Visit 6 (follow up) will occur one month after medication/placebo is complete.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
100mg of DCS will be administered orally in pill form daily for 4 weeks
A placebo will be administered orally daily for 4 weeks
Boston University
Boston, Massachusetts, United States
Immediate Recall Using the Logical Memory Test I
The Logical Memory Test I will be used to evaluate immediate auditory memory and ability to recall details of orally presented stories right after hearing them. Two stories will be presented and each story contains 25 standard memory details (story units). A participant receives 1 point for every detail they successfully recall. Scores can range from 0 to 50.
Time frame: 8 weeks
Delayed Recall Using the Logical Memory Test II
The Logical Memory Test II will be used to evaluate delayed auditory memory and ability to recall details of orally presented stories after a delay of 20-30 minutes after hearing them. Two stories will be presented and each story contains 25 standard memory details (story units). A participant receives 1 point for every detail they successfully recall. Scores can range from 0 to 50.
Time frame: 8 weeks
Overall Psychological Distress or Negative Mood State
The Total Mood Disturbance (TMD) score is a comprehensive metric used in psychology and sports science to quantify an individual's overall psychological distress or negative mood state. It is calculated directly from the 65 item Profile of Mood States (POMS) questionnaire where each item is scored on a 5-point Likert scale: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a lot, 4 = Extremely. . The TMD score combines multiple subscales of mood by summing negative emotional dimensions and subtracting positive ones. Score ranges from -32 to 200. Higher Scores indicate a greater degree of mood disturbance, affective distress, or psychological stress.
Time frame: 8 weeks
Transient Emotional States and Mood Fluctuations Over Time
The Profile of Mood States (POMS) is a standard, validated psychological test used to measure transient emotional states and mood fluctuations over time. It consists of 65 words or statements that describe different feelings and emotions. Each item is scored on a 5-point Likert scale: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a lot, 4 = Extremely. Scores can range from 0-60.
Time frame: 8 weeks
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