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Funding finished
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| University of Texas Southwestern Medical Center | OTHER |
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The goal of this study is to investigate long-term modulation of pain pathways leading to a suppression of pain symptoms in Gulf War Illness patients by applying transcranial direct current stimulation.
Gulf War Illness is a chronic and multisymptomatic disorder affecting returning military veterans of the 1990-1991 Gulf war. Pain is a major complaint of Gulf War Illness patients and is a leading cause of disability in veterans diagnosed with musculoskeletal ailments including joint and muscle pain, muscle fatigue, difficulty with lifting objects, and extremity paresthesia's. As a result, the target of the present study is the treatment of the pain symptoms, as this is detectable across all Gulf War Illness case classification systems.
Transcranial Direct current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has already demonstrated to improve pain symptoms in other patient populations, e.g. fibromyalgia patients. To investigate whether we can improve pain symptoms in GWI patients with pain complaints, we will compare behavioral (questionnaires) and electrophysiological (Electroencephalography) measures before and immediately after 10 sessions of tDCS and on several follow up sessions after the last tDCS from 2 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Active tDCS |
|
| Sham tDCS | Sham Comparator | Sham tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | Active tDCS will be adminestered |
| |
| Sham tDCS |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | Pain symptoms changes will be assessed by a Visual Analogue Scale for pain and the results will be compared between the two groups (active tDCS and sham tDCS) to study any possible differences occurring throughout the sessions. 0 no pain - 100 cm maximum pain you can imagine. | Before tDCS stimulation (baseline), immediately after (immediate-post) tDCS intervention measurements and 1 week, 4 weeks, 12 weeks and 24 weeks after the last tDCS session. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Vanneste, PhD | The University of Texas at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States | ||
| University of Texas at Dallas |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | Active tDCS Active tDCS: Active tDCS will be adminestered |
| FG001 | Sham tDCS | Sham tDCS Sham tDCS: Sham tDCS will be administered |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | Active tDCS Active tDCS: Active tDCS will be adminestered |
| BG001 | Sham tDCS | Sham tDCS Sham tDCS: Sham tDCS will be administered |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | Pain symptoms changes will be assessed by a Visual Analogue Scale for pain and the results will be compared between the two groups (active tDCS and sham tDCS) to study any possible differences occurring throughout the sessions. 0 no pain - 100 cm maximum pain you can imagine. | We had to stop collection of our data-collection due to COVID, as the IRB did not allow us to continue to collect human data. | Posted | Mean | Standard Deviation | score on a scale | Before tDCS stimulation (baseline), immediately after (immediate-post) tDCS intervention measurements and 1 week, 4 weeks, 12 weeks and 24 weeks after the last tDCS session. |
|
6 months
adverse event and/or serious adverse event, used to collect adverse event information, do not differ from the clinicaltrials.gov Definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | Active tDCS Active tDCS: Active tDCS will be adminestered | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sven Vanneste | UTDallas | n/a | sven.vanneste@utdallas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2017 | Aug 8, 2024 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2017 | Jan 31, 2025 | SAP_009.pdf |
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| ID | Term |
|---|---|
| D018923 | Persian Gulf Syndrome |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D000067398 | War-Related Injuries |
| D014947 | Wounds and Injuries |
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| Device |
Sham tDCS will be administered |
|
| Richardson |
| Texas |
| 75080 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Sham tDCS |
Sham tDCS Sham tDCS: Sham tDCS will be administered |
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Sham tDCS | Sham tDCS Sham tDCS: Sham tDCS will be administered | 0 | 3 | 0 | 3 | 0 | 3 |
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