CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
Active tDCS +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03371225
NCT03371225N/ACompleted
CompareCT.gov

Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System

Spaulding Rehabilitation Hospital·interventional·Posted Dec 13, 2017·Updated Dec 10, 2025

In Brief

A clinical study evaluating Active tDCS, Active Exercise, and 2 other interventions for Fibromyalgia. Completed, enrolled 116 participants across 1 site.

Detailed Summary

This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)\] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial \[tDCS (active and sham) and aerobic exercise (AE) (active and control)\] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 13, 2017
Enrollment StartMay 1, 2019
Primary CompletionSep 26, 2024
Study CompletionOct 26, 2025
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.6 years ago

Interventions

Active tDCSdevice

Active tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. 20 minutes of tDCS will be applied.

Active Exerciseprocedure

Participants will walk briskly in a treadmill (as to keep at 60-70% maximum heart rate) for 30 minutes

Sham tDCSdevice

Active tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. Only 30 seconds of current will be applied for the sham condition.

Sham Exerciseprocedure

Participants will walk in a treadmill (as to keep at 10% within their baseline heart rate) for 30 minutes.