Repetitive Transcranial Magnetic Stimulation for Fibromyalgia

(rTMS Trial)

Overseen By Olivia Caraccio, BS/BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Tricyclics, Antipsychotics, Bupropion, Methadone

Disqualifiers: Stroke, Schizophrenia, Bipolar, Substance misuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called repetitive transcranial magnetic stimulation (rTMS) to observe its effects on brain activity in people with fibromyalgia, a condition causing widespread pain. Researchers aim to determine if rTMS alters the function of the brain's movement control areas (motor cortices) and whether treating the right or left side of the brain makes a difference. Women who have experienced fibromyalgia pain for at least three months and report pain levels of 4 out of 10 or higher are suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new insights and treatments for fibromyalgia.

What prior data suggests that this technique is safe for fibromyalgia?

Studies have shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people with fibromyalgia, with most experiencing no serious side effects. Research indicates that rTMS can reduce chronic pain and improve quality of life, with pain relief lasting up to 8 weeks after treatment.

A meta-analysis, which combines results from many studies, confirms that rTMS is both safe and effective for managing fibromyalgia symptoms, including pain relief and overall well-being. Although rTMS is usually safe, discussing any concerns with a healthcare provider before starting a new treatment is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about repetitive transcranial magnetic stimulation (rTMS) for fibromyalgia because it offers a non-invasive approach that targets the brain directly. Unlike standard treatments like pain medications and antidepressants, rTMS uses magnetic fields to stimulate nerve cells, which may help modulate pain perception. Additionally, rTMS is unique in that it can be applied to different areas of the brain, such as the right or left motor cortex (M1), potentially offering tailored relief based on individual needs. This method provides a promising alternative for patients seeking options beyond traditional pharmaceuticals, with the potential for fewer side effects.

What evidence suggests that repetitive transcranial magnetic stimulation might be an effective treatment for fibromyalgia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) on the primary motor cortex (M1) can help manage pain in fibromyalgia. Studies have found that this treatment can greatly reduce pain, with some patients experiencing relief for up to eight weeks. In this trial, participants will receive either right M1 rTMS or left M1 rTMS. Both approaches have proven helpful for controlling pain in fibromyalgia and other long-term pain conditions. One study specifically noted that left M1 rTMS significantly reduced fibromyalgia pain after ten sessions. Overall, current research suggests that rTMS is a promising option for easing fibromyalgia pain. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for right-handed women aged 18 to 65 with fibromyalgia diagnosed by a physician, experiencing pain intensity of at least 4/10. Participants must be in stable health, speak English, and have consistent medication doses for mood, pain, and sleep disorders. Exclusions include significant medical diseases, substance misuse history, MRI-incompatible implants, pregnancy, certain psychiatric disorders or medications.

Inclusion Criteria

Generally stable health

Ability to read and speak English and willingness to understand instructions and questionnaires

Signing an informed consent document after explanation of the study

Exclusion Criteria

Significant other medical diseases

Current or history of substance misuse/dependence

Intra-axial implants that are MRI incompatible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment targeting the right or left motor cortex over 10 sessions

2 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for changes in brain activity, pain, and other symptoms post-treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests how rTMS affects brain activity in fibromyalgia patients. It examines changes in motor cortices response and differences between the brain's hemispheres when one side receives treatment. The goal is to understand if rTMS can alter brain function related to chronic pain management.

How Is the Trial Designed?

Group I: right M1 rTMS Active Control 1 Intervention

Group II: Left M1 rTMS Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9139594/

Effects of Repetitive Transcranial Magnetic Stimulation on the ... In a related meta-analysis, stimulation of the primary motor cortex (M1) with rTMS was effective for pain control in chronic pain and fibromyalgia [9,11,12].

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07260864

Investigating the Effects of Repetitive Transcranial ... The first goal of this study is to see how brain activity changes in people with fibromyalgia after they get a treatment called rTMS ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225001023

Motor cortex repetitive transcranial magnetic stimulation in ... Primary outcome was ≥50% pain reduction at week 8 compared with baseline. Secondary outcomes included pain interference, mood, global impression of change, ...

4. archives-pmr.org archives-pmr.org/article/S0003-9993(22)00413-0/abstract

Efficacy of High-Frequency Repetitive Transcranial ... Ten sessions of adjunctive left prefrontal rTMS significantly reduces fibromyalgia pain: a randomized, controlled pilot study. Pain. 2011 ...

5. link.springer.com link.springer.com/article/10.1007/s40122-025-00770-2

Effect of Repetitive Transcranial Magnetic Stimulation on ... Our data revealed a significant reduction of symptoms in both the treatment and sham groups, indicating a strong placebo effect of sham rTMS.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11204413/

Repetitive Transcranial Magnetic Stimulation in Fibromyalgia This meta-analysis demonstrated the safety and efficacy of rTMS in treating various aspects of fibromyalgia symptoms, including quality of life, pain, and, ...

7. nature.com nature.com/articles/s41598-022-21557-x

Resting-state functional connectivity predicts motor cortex ... We investigated whether the strength of connectivity between networks of brain areas that are associated with FMS symptomatology and pain relief ...

8. journals.lww.com journals.lww.com/painrpts/fulltext/2025/02000/repetitive_transcranial_magnetic_stimulation_for.18.aspx

Repetitive transcranial magnetic stimulation for fibromyalgia Repetitive transcranial magnetic stimulation (rTMS) has increasingly been used to modify cortical maladaptive plastic changes shown to occur in fibromyalgia ...