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Procedure

rTMS for Fibromyalgia

N/A

Waitlist Available

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention

Awards & highlights

Study Summary

This trial investigates the neurophysiology of fibromyalgia to find potential biomarkers for diagnosis & explore if transcranial magnetic stimulation can improve pain.

Who is the study for?

This trial is for adults aged 18-65 who have been diagnosed with fibromyalgia, a condition causing fatigue and chronic pain. It's not open to those with other chronic pain conditions or who can't safely undergo Transcranial Magnetic Stimulation (TMS) due to certain health risks.Check my eligibility

What is being tested?

The study tests how Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, affects the neurophysiology of fibromyalgia patients compared to inactive treatment. Participants will receive two weeks of either active rTMS or sham (inactive) therapy.See study design

What are the potential side effects?

rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The sham procedure has minimal risk as it mimics rTMS without delivering actual stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and experiment 1: at baseline pre-intervention and immediately following 1 treatment session, experiment 2: at baseline pre-intervention and 2 weeks post-intervention for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Fibromyalgia impact questionnaire (FIQ)

Change in PROMIS-29 v2.0 Profile

Secondary outcome measures

Change in Motor-evoked potentials (MEPs)

Change in Pain catastrophizing scale-EN-SF

Change in Patient Health Questionnaire-4 (PHQ-4)

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active rTMSActive Control1 Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered at 10 Hz, 1500 pulses targeting the hand representation of the left primary motor cortex. rTMS delivery will require ~11 min to complete. In Experiment 1, this intervention will be performed for 1 session (~11min). In Experiment 2, this intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Group II: Sham rTMSPlacebo Group1 Intervention

Sham rTMS will be delivered at as a placebo control. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active rTMS. In Experiment 2, this intervention will be performed approximately 5 days per week for 2 weeks. In addition, participants will experience their standard medical care.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

McMaster UniversityLead Sponsor

880 Previous Clinical Trials

2,597,768 Total Patients Enrolled

Frequently Asked Questions

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

Is there a way for me to contribute to this trial?

"To qualify for this trial, applicants must suffer from fibromyalgia and be between 20 to 65 years old. 60 participants are sought in total."

Answered by AI

Do the age restrictions for this research allow people below seventy years of age to participate?

"According to the inclusion criteria, participants between 20 and 65 years old are eligible for this research project. There are 6 studies that cater specifically to those under 18 while 81 other trials target individuals above 65 years of age."

Answered by AI

Is enrollment still available for this research endeavor?

"Data hosted on clinicaltrials.gov reveals that this trial is no longer taking applications at present, with the initial posting dating back to September 1st 2023 and last update being August 16th 2023. Although it does not need any more participants for now, there are 114 other trials which are actively seeking patients."

Answered by AI

What objectives does this research endeavor aim to fulfill?

"The primary assessment made during this experiment is the Change in Fibromyalgia Impact Questionnaire (FIQ). Additionally, researchers will also monitor changes to the Patient Health Questionnaire-4 (PHQ-4) as an indicator of Major Depressive Disorder and Generalized Anxiety Disorder symptoms, Short-form Posttraumatic Checklist-5 (Short Form PCL) for Post Traumatic Stress Syndrome indicators, and Motor Evoked Potentials obtained through Transcranial magnetic stimulation assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurophysiology of Fibromyalgia

Aimee Nelson 2023. "Neurophysiology of Fibromyalgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006130.

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