Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia

NCT07260864 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY0000010795Schmitt program
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The first goal of this study is to see how brain activity changes in people with fibromyalgia after they get a treatment called rTMS (repetitive transcranial magnetic stimulation). Researchers are looking at how the parts of the brain that control movement (called motor cortices) respond to this treatment. The second goal is to find out if the changes in brain activity are different between the right and left sides of the brain, depending on which side gets the treatment.

Conditions

Fibromyalgia (FM)

Keywords

Transcranial Magnetic Stimulation; Chronic Pain; Nociplastic pain; Functional Magnetic Resonance Imaging; Motor Cortex

Outcome Measures

Primary Outcomes (1)

• Mean Change in Primary Motor Cortex (M1) Connectopy Profile

  Resting-state fMRI will be used to derive connectopy embeddings of the primary motor cortex (M1). Connectopy embeddings from the stimulated side will be extracted from significant baseline-defined clusters. A single value per participant is derived by averaging the embedding values within this cluster. Higher scores indicate increased similarity to healthy reference profiles (improved functional connectivity), while lower scores indicate deviation from healthy reference patterns (reduced functional connectivity).

  Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).

Secondary Outcomes (14)

• Mean Change in Pain Intensity (Numeric Rating Scale, NRS)

  Baseline and post-treatment (following 10 rTMS sessions, within 7 days of completing rTMS sessions ).

• Mean Change in Pressure Pain Threshold (PPT)

  Baseline and post-treatment (within 7 days of completing rTMS sessions )

• Mean Change in Fatigue (Patient-Reported Outcomes Measurement Information System-PROMIS Fatigue 13a Subscale)

  Baseline and post-treatment (within 7 days of completing rTMS sessions).

• Mean Change in Sleep Disturbance (Patient-Reported Outcomes Measurement Information System - PROMIS Sleep Disturbance 8a Subscale)

  Baseline and post-treatment (within 7 days of completing rTMS sessions).

• Mean Change in the Short-Form McGill Pain Questionnaire

  Baseline and post-treatment (within 7 days of completing rTMS sessions).

Study Arms (2)

right M1 rTMS

ACTIVE COMPARATOR

Other: rTMS

Left M1 rTMS

ACTIVE COMPARATOR

Other: rTMS

Interventions

rTMS OTHER

Using rTMS, which is a procedure that uses magnetic fields to stimulate nerve cells in the brain, to investigate its potential analgesic effects in fibromyalgia.

Left M1 rTMS; right M1 rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 18 to 65, right-handed, with no racial/ethnic restrictions.
• A diagnosis of fibromyalgia by a qualified physician according to the American College of Rheumatology 2016 criteria
• Must have a history of fibromyalgia pain for a duration ≥ 3 months, as it is included in the diagnostic criteria.
• Must have pain intensity equal or greater than 4/10 on the numerical rating scale (NRS) at enrollment.
• Concurrent chronic overlapping pain conditions (except migraine with aura), depression, and anxiety will be allowed when mild to moderate (Less than 31 on Beck Depression Inventory or less than 36 on Beck Anxiety Inventory), except in cases with psychotic or manic features.
• Concomitant medication (except tricyclics, antipsychotic medications, bupropion, methadone, theophylline) and their doses for mood, pain and sleep disorders must be steady at least 4 weeks before enrolment and must be kept at a steady dosage during the trial.
• Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires.
• Must be in generally stable health.
• Must sign an informed consent document after explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

You may not qualify if:

• Inability to provide informed consent.
• Age outside the studied range (i.e., \< 18, \> 65).
• Patients planning to change their medications during trial.
• Participants who are currently receiving other alternative therapies during trial (e.g., physiotherapy, acupuncture).
• History of receiving TMS, transcranial direct current stimulation (tDCS), or electroconvulsive therapy (ECT).
• Evidence of rheumatologic disorders, autoimmune diseases, taking immunosuppressive treatment, severe or unstable cardiac diseases.
• Fibromyalgia must be the primary complaint; hence patients cannot have another main source of pain (e.g., osteoarthritis). Patients will be asked to shade all the areas in which they experience pain on a body map. If they shade areas other than typical fibromyalgia pain, we will discuss any previous diagnosis, the intensity and chronicity of pain, and exclude them if chronic pain in any area outside the condition in to be studied is confirmed.
• Involvement in litigation regarding their pain or having a disability claim or receiving workman compensation or seeking either because of their pain.
• Any history of hemorrhagic or thrombotic stroke.
• Current use of tricyclic antidepressants or any antipsychotic medications, given the risk of seizure incidence independent of TMS use in tricyclics is up to 0.4% or second-generation antipsychotics up to 1.2%.
• History of traumatic brain injury
• History of epileptic disorders or family history of seizures in first degree relatives
• History of syncope
• History of tinnitus or hearing loss
• Current or history of substance misuse/dependence including alcohol at time of entry into the study.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Nociplastic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Olivia Caraccio, BS/BA

CONTACT

5853136322; Olivia_Caraccio@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will utilize single-blind as blinded outcome assessment, ensuring that investigators responsible for outcome evaluation and data analysis remain blinded to patients and whether treatment was delivered to the right or left motor cortex (M1). However, the clinician administering rTMS will not be blinded to the intervention arm (right vs left).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of psychiatry

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: December 3, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)