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Trial Outcomes & Findings for Transcranial Direct Current Stimulation for Pain Treatment in Gulf War Illness. (NCT NCT03547869)

NCT ID: NCT03547869

Last Updated: 2025-02-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

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.

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure
Active tDCS
Active tDCS Active tDCS: Active tDCS will be adminestered
Sham tDCS
Sham tDCS Sham tDCS: Sham tDCS will be administered
Overall Study
STARTED
6
3
Overall Study
COMPLETED
2
1
Overall Study
NOT COMPLETED
4
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active tDCS
n=6 Participants
Active tDCS Active tDCS: Active tDCS will be adminestered
Sham tDCS
n=3 Participants
Sham tDCS Sham tDCS: Sham tDCS will be administered
Total
n=9 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: We had to stop collection of our data-collection due to COVID, as the IRB did not allow us to continue to collect human data.

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.

Outcome measures

Outcome measures
Measure
Active tDCS
n=6 Participants
Active tDCS Active tDCS: Active tDCS will be adminestered
Sham tDCS
n=3 Participants
Sham tDCS Sham tDCS: Sham tDCS will be administered
Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain .
Baseline
67.1 score on a scale
Standard Deviation 5.35
68.2 score on a scale
Standard Deviation 6.98
Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain .
immediate after
53.21 score on a scale
Standard Deviation 9.10
63.21 score on a scale
Standard Deviation 7.90
Pain Symptom Changes Will be Measured by a Visual Analogue Scale for Pain .
week 1
54.23 score on a scale
Standard Deviation 12.91
64.20 score on a scale
Standard Deviation 13.45

Adverse Events

Active tDCS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sven Vanneste

UTDallas

Phone: n/a

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place