Gulf War Illness
Conditions
Keywords
Gulf War, D-cycloserine, Neuroinflammation, Cognition, Memory
Brief summary
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.
Detailed description
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.
Interventions
DRUGD-cycloserine
100mg of DCS will be administered orally in pill form daily for 4 weeks
DRUGPlacebo
A placebo will be administered orally daily for 4 weeks
Sponsors
Boston University Charles River Campus
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
43 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Veterans of the 1991 Gulf War, male or female * Physical examination and laboratory findings within normal limits * Willingness and ability to participate in the informed consent process and comply with study protocols * Symptom criteria: Meets Gulf War Illness criteria with the cognitive symptom domain being present. Veteran does not have medical exclusions for Gulf War Illness
Exclusion criteria
* Veteran lacks the capacity to provide consent during the informed consent process * Veteran has the one of the following medical exclusion conditions and/or has been active or received treatment within the past 5 years: Cancer (except nonmelanoma skin cancer), diabetes (not well managed), seizure disorder, heart disease (except hypertension), liver disease, kidney disease, Lupus, multiple sclerosis, stroke, chronic infectious disease, immune disorder/immunosuppression * Veteran has a history of a major psychiatric or central nervous system disorder that can affect cognitive function (ie. epilepsy, brain tumor, Parkinson's Disease) * Veteran has been hospitalized in the past 5 years for depression, PTSD, alcohol or drug dependence * Veteran has current suicidal ideation or current alcohol or drug dependence * Pregnant women, lactating women, women who are breastfeeding, or women of childbearing potential who are not using medically accepted forms of contraception * Veteran is active duty personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Recall Using the Logical Memory Test I | 8 weeks | 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. |
| Delayed Recall Using the Logical Memory Test II | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Psychological Distress or Negative Mood State | 8 weeks | 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. |
| Transient Emotional States and Mood Fluctuations Over Time | 8 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRosemary Toomey, Ph.D.
Boston University
Participant flow
Pre-assignment details
22 participants were enrolled, 2 voluntarily withdrew, 3 were lost to contact, 2 were withdrawn by the PI
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 6 |
| Current Military Status National Guard | 1 Participants |
| Current Military Status Retired | 4 Participants |
| Current Military Status Veteran | 3 Participants |
| Gulf War Duty Service Active | 5 Participants |
| Gulf War Duty Service National guard | 0 Participants |
| Gulf War Duty Service Reserve | 2 Participants |
| Military Rank Enlisted | 12 Participants |
| Military Rank NCO | 0 Participants |
| Military Rank Officer | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian | 15 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 3 / 7 | 0 / 9 |
| serious Total, serious adverse events | 0 / 7 | 0 / 9 |
Outcome results
None listed