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Behavioural Intervention

tDCS + Exercise for Fibromyalgia

N/A
Waitlist Available
Led By Felipe Fregni, MD PhD MPH
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 4 on a 0-10 VAS scale) without other comorbid chronic pain diagnosis
Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine
Must not have
Severe depression (with a score of >30 on the beck depression inventory)
Previous significant neurological history (e.g., traumatic brain injury), resulting in neurological deficits, such as cognitive or motor deficits, as self-reported
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks

Summary

This trial is testing whether a combination of transcranial direct current stimulation and exercise can help control pain in patients with fibromyalgia.

Who is the study for?
Adults aged 18-65 with fibromyalgia, experiencing pain for over 6 months and resistant to common painkillers. Participants must be able to feel touch on their forearm and provide informed consent. Excluded are those with unstable medical/psychiatric disorders, substance abuse history, significant neurological issues or surgeries, high opiate use, severe depression, or pregnancy.
What is being tested?
The trial is testing the combination of transcranial direct current stimulation (tDCS) and exercise on pain control in fibromyalgia patients. It will compare active tDCS with sham (placebo) tDCS and active exercise with sham exercise over four weeks to see which methods best engage the body's natural pain regulation.
What are the potential side effects?
Potential side effects of tDCS may include mild tingling, itching or discomfort at the electrode site during application. Exercise might cause typical muscle soreness. Serious side effects are not commonly associated but will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with fibromyalgia pain, lasting more than 6 months and averaging at least a 4 on the pain scale, with no other chronic pain conditions.
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My pain doesn't improve with common painkillers like Tylenol or Ibuprofen.
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe depression, as indicated by a high score on a depression test.
Select...
I have had a serious brain injury that affects my thinking or movement.
Select...
I am currently taking high doses of pain medication.
Select...
I do not have any serious or unstable health or mental conditions.
Select...
I have had brain surgery involving opening the skull.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Conditioning Pain Modulation (CPM)
Pain
Secondary study objectives
Pain
Beck Depression Inventory (BDI)
EEG
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active tDCS and Active ExerciseExperimental Treatment2 Interventions
Active tDCS for 20 min Active exercise (60-70% max HR) for 30 min
Group II: Sham tDCS and Active ExerciseActive Control2 Interventions
Sham tDCS for 20 min Active exercise (60-70% max HR) for 30 min
Group III: Active tDCS and Sham ExerciseActive Control2 Interventions
Active tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min
Group IV: Sham TDCS and Sham ExercisePlacebo Group2 Interventions
Sham tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Exercise
2014
N/A
~230
Active tDCS
2012
Completed Phase 1
~1190

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
139 Previous Clinical Trials
10,985 Total Patients Enrolled
5 Trials studying Fibromyalgia
372 Patients Enrolled for Fibromyalgia
Felipe Fregni, MD PhD MPHPrincipal Investigator - Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
5 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Fibromyalgia
20 Patients Enrolled for Fibromyalgia

Media Library

tDCS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03371225 — N/A
Fibromyalgia Research Study Groups: Active tDCS and Active Exercise, Sham tDCS and Active Exercise, Active tDCS and Sham Exercise, Sham TDCS and Sham Exercise
Fibromyalgia Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT03371225 — N/A
tDCS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03371225 — N/A
Fibromyalgia Patient Testimony for trial: Trial Name: NCT03371225 — N/A
~18 spots leftby Dec 2025
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