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

Overview

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.

Full Title of Study: “Investigating Pain in Gulf War Illness With Transcranial Direct Current Stimulation.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 12, 2021

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

  • Device: Active tDCS
    • Active tDCS will be adminestered
  • Device: Sham tDCS
    • Sham tDCS will be administered

Arms, Groups and Cohorts

  • Experimental: Active tDCS
    • Active tDCS
  • Sham Comparator: Sham tDCS
    • Sham tDCS

Clinical Trial Outcome Measures

Primary Measures

  • Pain symptom changes will be measured by a Visual Analogue Scale for pain .
    • 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.
    • 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.

Secondary Measures

  • Electroencephalography (EEG) recordings will be used to asses changes in brain activity.
    • 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.
    • Brain activity will be recorded using electrodes connected to an EEG system and the recorded brain waves will be compared between the two groups (active tDCS and sham tDCS) to monitor any changes in brain patterns that might occur throughout the sessions.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 78 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas at Dallas
  • Collaborator
    • United States Department of Defense
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sven Vanneste, Associate professor – The University of Texas at Dallas
  • Overall Official(s)
    • Sven Vanneste, PhD, Principal Investigator, The University of Texas at Dallas
  • Overall Contact(s)
    • Sven Vanneste, PhD, 9728837275, GWI.Lab_CLINT@utdallas.edu

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