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Behavioural Intervention

tDCS + Exercise for Fibromyalgia

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Conditioning Pain Modulation (CPM)

Pain

Secondary outcome measures

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 tDCS

2012

Completed Phase 3

~1150

Active Exercise

2014

N/A

~230

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

135 Previous Clinical Trials

10,939 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this experiment restricted to persons over 84 years of age?

"This clinical trial is only open to adults aged 18-65. However, there are 7 trials available for those younger than 18 and 75 trials suitable for people above the age of 65."

Answered by AI

What is the aggregate of participants engaged in this research?

"Affirmative. As noted on clinicaltrials.gov, this medical study is actively enrolling patients since its posting date of May 1st 2019 and last update from August 11th 2022. The research team requires a total of 148 individuals to be recruited across one specified site."

Answered by AI

May I partake in this research project?

"This medical trial is looking to enrol 148 sufferers of fibromyalgia, aged between 18 and 65. To qualify, these patients must exhibit FM pain according to the ACR 2010 criteria (0-10 VAS scale average score of 4+), be unresponsive to typical medications for chronic ache such as Aspirin and Tylenol, remain capable of sensing touch from Von Frey fibers on their arm, and fall within the specified age range."

Answered by AI

Is enrolment in this experiment accessible to the public?

"As indicated on the clinicaltrials.gov website, this study is actively looking for participants and was posted on May 1st 2019 with its most recent update having been made on August 11th 2022."

Answered by AI

What are the primary goals of this experiment?

"This clinical trial aims to evaluate the effects of Conditioning Pain Modulation (CPM) over 6 weeks. Secondary objectives include assessing Exercise Adverse Effects, Quality of Life Scale (QoLS), and Average Pain Intensity as Assessed by Modified Brief Pain Inventory (BPI) - short form. During AE sessions, vital signs such as heart rate variability will be monitored in order to identify any potential discomfort or adverse reactions from physical exertion. As recommended by ACSM guidelines for AE in patients with FM, pain and fatigue levels will be continuously measured using a VAS scale throughout all tests; emergency procedure protocols outlined by ACSM must"

Answered by AI

Who else is applying?

What state do they live in?

Pennsylvania

What site did they apply to?

Spaulding Rehabilitation Network Research Institute

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Unmanageable pain for over 2 years, nothing helps. I have received physical therapy, chiropractic, acupuncture as well as many medications. I know that I must keep active to help treat fibromyalgia, but it has been difficult to find the right kind of exercise. I'm hoping Cognitive Behavior Therapy will help me at this point.

PatientReceived no prior treatments