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

Primary Purpose

Gulf War Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active tDCS

Sham tDCS

About this trial

This is an interventional basic science trial for Gulf War Syndrome focused on measuring Transcranial Direct Current Stimulation, Gulf War Illness, Pain modulation

Eligibility Criteria

45 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female US military veterans serving during the 1990-1991 Gulf War.
Men and women between the ages of 18 and 50 years old during service in the Gulf War (born between 1940 and 1973).
English speakers.

Exclusion Criteria:

Non-English speakers.
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.
No subjects will be enrolled who are cognitively or clinically incompetent to give informed consent.
Subjects cannot be taking medications that include: amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole,or citalopram.
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.

Sites / Locations

University of Texas Southwestern Medical Center
University of Texas at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Active tDCS

Sham tDCS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03547869

First Posted

March 16, 2018

Last Updated

January 25, 2022

Sponsor

The University of Texas at Dallas

Collaborators

United States Department of Defense, University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03547869

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Funding finished

Study Start Date

March 12, 2018 (Actual)

Primary Completion Date

January 25, 2022 (Actual)

Study Completion Date

January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas at Dallas

Collaborators

United States Department of Defense, University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gulf War Syndrome

Keywords

Transcranial Direct Current Stimulation, Gulf War Illness, Pain modulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Experimental

Arm Description

Active tDCS

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

Sham tDCS

Intervention Type

Device

Intervention Name(s)

Active tDCS

Intervention Description

Active tDCS will be adminestered

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

Sham tDCS will be administered

Primary Outcome Measure Information:

Title

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

Description

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.

Secondary Outcome Measure Information:

Title

Electroencephalography (EEG) recordings will be used to asses changes in brain activity.

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female US military veterans serving during the 1990-1991 Gulf War. Men and women between the ages of 18 and 50 years old during service in the Gulf War (born between 1940 and 1973). English speakers. Exclusion Criteria: Non-English speakers. 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. No subjects will be enrolled who are cognitively or clinically incompetent to give informed consent. Subjects cannot be taking medications that include: amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole,or citalopram. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sven Vanneste, PhD

Organizational Affiliation

The University of Texas at Dallas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

University of Texas at Dallas

City

Richardson

State/Province

Texas

ZIP/Postal Code

75080

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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