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NCT03371225 · ClinicalTrials.gov registry record · NA
Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
A NA study, sponsored by Spaulding Rehabilitation Hospital.
- Completed
- Registry status
- NA
- Development phase
- 116
- Enrollment target
NCT03371225: Completed NA study, sponsored by Spaulding Rehabilitation Hospital.
NCT03371225 is a NA study that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 116 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03371225, a NA study, has completed, sponsored by Spaulding Rehabilitation Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 116 participants
- Enrollment target
Study 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.
Primary Outcome
Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6). Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings. Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was
Interventions
- DEVICE Sham tDCS
- DEVICE Active tDCS
- PROCEDURE Active Exercise
- PROCEDURE Sham Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2025-10-26 |
| Phase | NA |
What the finished NCT03371225 record still lists
NCT03371225 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Sham tDCS is the first listed.
NCT03371225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03371225 about?
NCT03371225 is a clinical study titled "Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System". 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...
What is the current status of trial NCT03371225?
This trial is currently completed. It is a NA study. The enrollment target is 116 participants. The study started on 2019-05-01. Estimated completion is 2025-10-26.
What interventions are being tested in trial NCT03371225?
The interventions under investigation include: Sham tDCS (DEVICE), Active tDCS (DEVICE), Active Exercise (PROCEDURE), Sham Exercise (PROCEDURE).
Who is sponsoring clinical trial NCT03371225?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03371225's enrollment target sits among peer trials
116 808th of 2000 higher than 1,191 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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