Fibromyalgia (FM)rTMSNCT07260864
Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia
A study testing rTMS in people with Fibromyalgia (FM), run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- rTMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- History of schizophrenia, schizoaffective disorder, bipolar disorders, mania, hypomania, eating disorders, or any psychiatric illness with psychotic features (major depressive disorder, mild to moderate without psychosis, or anxiety disorders are not exclusion criteria).
- 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%.
- Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, sleep apnea, or malignancy. Stable diabetes mellitus, stable hypertension (meaning that these conditions are followed up on by a physician and they are getting treatment for it with clinical stability), or hyperlipidemia are not exclusion criteria.
- 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.
- History of COVID-19 infection with persistent neurologic symptoms.
- Intra-axial implants (e.g., spinal cord stimulators or pumps) that are MRI incompatible.
- All exclusion criteria for MRI and TMS safety: any metallic implants, chips, or plates, cochlear implants, brain or skull abnormalities, aneurysm clips or coils, non-removable piercings, tattoos containing ferromagnetic ink, and claustrophobia.
- Surgery within the past 3 months or history of any brain surgery
- Pregnancy
- Participation into another research study
- In the judgment of the investigator, unable or unwilling to follow the protocol and instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
Olivia Caraccio, BS, 5853136322, Olivia_Caraccio@URMC.Rochester.edu
About this study
Official title: Investigating the Differential Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Left and Right Motor Cortex in Fibromyalgia: A Prospective Randomized Trial With Functional Magnetic Resonance Imaging (MRI(
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.
Read the detailed description
The first aim of this study is to measure changes in fibromyalgia-related functional brain plasticity, as indicated by the functional "connectopy" of the right and left primary motor cortices in response to rTMS treatment. The second aim of this study is to explore whether changes in motor cortex connectopy differ between the right and left motor cortex (M1) following rTMS administered to each respective hemisphere.
- Conditions
- Fibromyalgia (FM)
- Being tested
- rTMS
- Keywords
- Transcranial Magnetic Stimulation, Chronic Pain, Nociplastic pain, Functional Magnetic Resonance Imaging, Motor Cortex
- Medical subject headings
- Fibromyalgia, Chronic Pain, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| right M1 rTMS | Active comparator | Not described Receives: Other: rTMS |
| Left M1 rTMS | Active comparator | Not described Receives: Other: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).
Secondary outcomes (14)
Mean Change in Pain Intensity (Numeric Rating Scale, NRS)
Self-reported average pain over 7 days using the Numeric Rating Scale (0 = "no pain at all" to 10 = "worst pain possible"). A single number is derived as the mean of daily ratings over 7 days. Lower scores indicate reduced pain intensity, while higher scores indicate worse pain intensity.
Measured: Baseline and post-treatment (following 10 rTMS sessions, within 7 days of completing rTMS sessions ).
Mean Change in Pressure Pain Threshold (PPT)
Pressure pain threshold (PPT) will be measured using a pressure algometer (Wagner Inc.). Pressure will be applied at a constant rate until participants indicate pain perception. The threshold (kg/cm²) will be recorded. A single value is derived by averaging three threshold readings from the target site. Higher thresholds indicate reduced pain sensitivity (improvement), while lower thresholds indicate increased pain sensitivity (worsening).
Measured: 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)
Fatigue will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 13a subscale, which ranges from 13 to 65. Higher scores indicate greater fatigue severity (worsening), whereas lower scores indicate less fatigue (improvement).
Measured: 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)
Sleep disturbance will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 8a subscale, which ranges from 8 to 40. Higher scores indicate greater sleep disturbance (worsening), whereas lower scores indicate improved sleep.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in the Short-Form McGill Pain Questionnaire
The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) has 22 items assessing continuous, intermittent, neuropathic, and affective pain. Items are rated 0-10, with total scores ranging 0-220, where higher scores indicate greater pain severity.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Central Sensitization Index
Central Sensitization Index (CSI) is a 25-item self-reported measure that determines whether the symptoms of patients are associated with central sensitization. Item responses are on a 4-point scale and can be answered as follows: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, and 4 = Always. The total score will be used to estimate the severity of the central sensitization symptoms.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) has 13 items measuring rumination, magnification, and helplessness related to pain. Items are rated 0-4, with total scores ranging 0-52; higher scores indicate greater catastrophizing.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in the Pain Self-repot Survey for the Assessment of Fibromyalgia
The Patient Self-Report Survey for the Assessment of Fibromyalgia has 9 items measuring widespread pain and symptom severity. Scores range 0-31, with higher scores indicating greater fibromyalgia symptom burden.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Revised Fibromyalgia Impact Questionnaire
The Revised Fibromyalgia Impact Questionnaire (FIQR) is a 21-item, three-domain, self-reported measure of the impact of fibromyalgia on life. All questions include a 0-10 scale, and different domains have different calculations (function domain divided by 3, overall impact domain divided by 1, symptom domain divided by 2) before summing all scores. The total score will be used to estimate the changes in quality of life with interventions.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality over the past month and consists of seven components assessing various aspects of sleep quality and sleep-related daytime functioning. The index will be used to estimate the overall sleep quality of participants, with total scores ranging from 0 to 21, where higher scores indicate worse sleep quality.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Chronic Overlapping Pain Conditions Screener
Chronic Overlapping Pain Conditions Screener (COPCS) is a self-report tool that uses a body map and trigger questions to screen for 10 chronic overlapping pain conditions and outputs the number of conditions present (0-10).
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) has 14 items, 7 each for anxiety and depression. Each item is rated 0-3, with subscale scores ranging 0-21; higher scores indicate greater symptom severity.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Beck Depression Inventory
The Beck Depression Inventory (BDI) has 21 items assessing depressive symptoms. Each item is rated 0-3, with total scores ranging 0-63; higher scores indicate greater depression severity.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) has 21 items assessing anxiety symptoms. Each item is rated 0-3, with total scores ranging 0-63; higher scores indicate greater anxiety severity.
Measured: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start5 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Geha, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260864
- Sponsor's protocol ID
- STUDY00010795
- Other IDs
- Schmitt program
- Acronym
- rTMS
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Differential Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Left and Right Motor Cortex in Fibromyalgia: A Prospective Randomized Trial With Functional Magnetic Resonance Imaging (MRI(
- ClinicalTrials.gov ID
- NCT07260864
- Acronym / sponsor ID
- rTMS / STUDY00010795
- Conditions
- Fibromyalgia (FM)
- Keywords
- Transcranial Magnetic Stimulation, Chronic Pain, Nociplastic pain, Functional Magnetic Resonance Imaging, Motor Cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The first aim of this study is to measure changes in fibromyalgia-related functional brain plasticity, as indicated by the functional "connectopy" of the right and left primary motor cortices in response to rTMS treatment. The second aim of this study is to explore whether changes in motor cortex connectopy differ between the right and left motor cortex (M1) following rTMS administered to each respective hemisphere.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right M1 rTMS | Active comparator | Other: rTMS |
| Left M1 rTMS | Active comparator | Other: rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSUsing rTMS, which is a procedure that uses magnetic fields to stimulate nerve cells in the brain, to investigate its potential analgesic effects in fibromyalgia. | Other | Left M1 rTMS, right M1 rTMS |
Primary outcome
Mean Change in Primary Motor Cortex (M1) Connectopy Profile
Time frame: Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).
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).
14 secondary outcomes
Mean Change in Pain Intensity (Numeric Rating Scale, NRS)
Time frame: Baseline and post-treatment (following 10 rTMS sessions, within 7 days of completing rTMS sessions ).
Mean Change in Pressure Pain Threshold (PPT)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in the Short-Form McGill Pain Questionnaire
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Central Sensitization Index
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Pain Catastrophizing Scale
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in the Pain Self-repot Survey for the Assessment of Fibromyalgia
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Revised Fibromyalgia Impact Questionnaire
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Chronic Overlapping Pain Conditions Screener
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Hospital Anxiety and Depression Scale
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Beck Depression Inventory
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Mean Change in Beck Anxiety Inventory
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Fibromyalgia (FM), run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Caraccio, BS/BA (5853136322, Olivia_Caraccio@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Primary Motor Cortex (M1) Connectopy Profile (time frame: Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.