Clinical trial NCT03547869: Transcranial Direct Current Stimulation for Pain Treatment in Gulf War Illness.
Official title: Investigating Pain in Gulf War Illness With Transcranial Direct Current Stimulation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gulf War Syndrome
Keywords: Transcranial Direct Current Stimulation
Gulf War Illness
Pain modulation
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Texas Southwestern Medical Center
First posted: 2018-06-06
Enrollment: 9
Sex: ALL
Minimum age (years): 45
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain .
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Richardson
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sven Vanneste, PhD
role: PRINCIPAL_INVESTIGATOR
References: