Transcranial Direct Current Stimulation for Pain Treatment in Gulf War Illness.

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2023-01-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gulf War Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active tDCS

Group Type EXPERIMENTAL

Active tDCS

Intervention Type DEVICE

Active tDCS will be adminestered

Sham tDCS

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

Sham tDCS will be administered

Interventions

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Active tDCS

Active tDCS will be adminestered

Intervention Type DEVICE

Sham tDCS

Sham tDCS will be administered

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No