NCT03547869

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

March 16, 2018

Results QC Date

February 14, 2023

Last Update Submit

January 31, 2025

Conditions

Gulf War Syndrome

Keywords

Transcranial Direct Current StimulationGulf War IllnessPain modulation

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Active tDCS

EXPERIMENTAL

Active tDCS

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

Sham tDCS

Device: Sham tDCS

Interventions

Active tDCSDEVICE

Active tDCS will be adminestered

Active tDCS
Sham tDCSDEVICE

Sham tDCS will be administered

Sham tDCS

Eligibility Criteria

Age45 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Persian Gulf Syndrome

Condition Hierarchy (Ancestors)

Occupational DiseasesWar-Related InjuriesWounds and Injuries

Results Point of Contact

Title
Sven Vanneste
Organization
UTDallas
sven.vanneste@utdallas.edu
n/a

Study Officials

  • Sven Vanneste, PhD

    The University of Texas at Dallas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 16, 2018

First Posted

June 6, 2018

Study Start

March 12, 2018

Primary Completion

January 25, 2022

Study Completion

January 25, 2023

Last Updated

February 3, 2025

Results First Posted

February 3, 2025

Record last verified: 2025-01

Locations

US(2)