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

Investigating Pain in Gulf War Illness With Transcranial Direct Current Stimulation.

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.

Study Overview

• Status: Terminated
• Conditions: Gulf War Syndrome
• Intervention / Treatment: Device: Active tDCS; Device: Sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Richardson, Texas, United States, 75080
      • University of Texas at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS	Device: Active tDCS; Active tDCS will be adminestered
Sham Comparator: Sham tDCS	Device: Sham tDCS; Sham tDCS will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography (EEG) recordings will be used to asses changes in brain activity.	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.	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.

Collaborators and Investigators

• Sponsor: The University of Texas at Dallas
• Collaborators: United States Department of Defense; University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Sven Vanneste, PhD, The University of Texas at Dallas

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Gulf War Illness; Pain modulation
• Additional Relevant MeSH Terms: War-Related Injuries; Wounds and Injuries; Occupational Diseases; Persian Gulf Syndrome
• Other Study ID Numbers: 17-88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes