Gulf War Syndrome
Conditions
Keywords
Transcranial Direct Current Stimulation, Gulf War Illness, Pain modulation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEActive tDCS
Active tDCS will be adminestered
DEVICESham tDCS
Sham tDCS will be administered
Sponsors
United States Department of Defense
University of Texas Southwestern Medical Center
The University of Texas at Dallas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female US military veterans serving during the 1990-1991 Gulf War. 2. Men and women between the ages of 18 and 50 years old during service in the Gulf War (born between 1940 and 1973). 3. English speakers.
Exclusion criteria
1. Non-English speakers. 2. History of a neurological disorder, including dementia of any type, moderate to severe traumatic brain injury (TBI), brain tumors, present or past drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis. Traumatic brain injury will be screened by history. 3. No subjects will be enrolled who are cognitively or clinically incompetent to give informed consent. 4. Subjects cannot be taking medications that include: amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole,or citalopram. 5. Subjects with cardiac pacemakers, implanted medication pumps of any sort, or a history of bad heart disease, a history of seizures and/or family members with a history of seizures, and/or the presence of any metal objects in or near the head which cannot be safely removed for the duration of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS Active tDCS
Active tDCS: Active tDCS will be adminestered | 6 |
| Sham tDCS Sham tDCS
Sham tDCS: Sham tDCS will be administered | 3 |
| Total | 9 |
Baseline characteristics
| Characteristic | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 3 |
| other Total, other adverse events | 0 / 6 | 0 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 |
Outcome results
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active tDCS | Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | Baseline | 67.1 score on a scale | Standard Deviation 5.35 |
| Active tDCS | Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | immediate after | 53.21 score on a scale | Standard Deviation 9.1 |
| Active tDCS | Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | week 1 | 54.23 score on a scale | Standard Deviation 12.91 |
| Sham tDCS | Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | Baseline | 68.2 score on a scale | Standard Deviation 6.98 |
| Sham tDCS | Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | immediate after | 63.21 score on a scale | Standard Deviation 7.9 |
| Sham tDCS | Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain . | week 1 | 64.20 score on a scale | Standard Deviation 13.45 |