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

Gulf War Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03547869
• Other study ID #: 17-88
• Status: Terminated
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: January 25, 2022

Study information

• Verified date: January 2022
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gulf War Syndrome
• Persian Gulf Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Texas at Dallas	Richardson	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas at Dallas	United States Department of Defense, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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.