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Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System

NCT03371225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-12-10

Study results available
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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.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Active tDCS

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.

PROCEDURE

Active Exercise

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

DEVICE

Sham tDCS

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.

PROCEDURE

Sham Exercise

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

Sponsors & Collaborators

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Felipe Fregni, MD PhD MPH · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2024-09-26
Completion
2025-10-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371225 on ClinicalTrials.gov