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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-cycloserine | Active Comparator | To compare efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI. DCS = d-cycloserine Dosage: 100mg Dosage form: Pill, administered orally Frequency: Daily for four weeks |
|
| Placebos | Placebo Comparator | To provide a control group to compare efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-cycloserine | Drug | Partial agonist of N-methyl-D-aspartate (NMDA) receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Test Battery | 8 weeks per subject |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Questionnaires | 8 weeks per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Coyne, B.S. | Contact | 617-358-3048 | afcoyne@bu.edu | |
| Rosemary Toomey, Ph.D. | Contact | 617-358-2037 | toomey@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rosemary Toomey, Ph.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebos | Drug | Sugar pill |
|
|
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |