FibromyalgiaMultiStimFMNCT07642882
Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients
A study testing rTMS in people with Fibromyalgia and Depression - Major Depressive Disorder, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial summary
Repetitive Transcranial Magnetic Stimulation (rTMS) of the motor cortex is a recognized analgesic technique for the treatment of fibromyalgia pain, which represents a largely unmet medical need. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia, Depression - Major Depressive Disorder, Chronic Pain
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Nov 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain lasting at least 6 months, with or without associated depressive symptoms;
- Fibromyalgia (2016 revised ACR criteria and a FIRST questionnaire score of at least 5 out of 6);
- Average pain intensity ≥ 4/10 on a 0-10 numeric rating scale;
- Pain present daily or almost daily (≥ 4 days per week);
- Patients aged over 18 and under 80 years;
- Patients who have provided written informed consent;
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- Patients whose analgesic treatment has been stable for at least 1 month prior to inclusion and will not need to be modified during the study;
- Patients who can be followed for the duration of the study (10 weeks);
- Patients covered by a health insurance plan or otherwise eligible.
Who cannot join
- Ongoing litigation;
- Contraindication to rTMS:
- Implanted electronic devices and/or conductive objects near the coil: Patients with an active implanted device that is activated or controlled by physiological signals (e.g., pacemakers, implantable cardiac defibrillators [ICD], vagus nerve stimulators [VNS], wearable cardioverter defibrillators [WCD], ocular implants, deep brain stimulation systems, drug infusion pumps or ports, intracardiac leads), even if the device has been removed.
- Non-removable metallic objects near the coil:** Patients with a conductive, ferromagnetic, or magnetically sensitive metal implant in the head or within 30 cm of the coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, or bullet fragments);
- Current abuse of drugs or psychoactive substances, including alcohol (according to DSM-5 criteria);
- Pregnancy or breastfeeding;
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- Epilepsy or a history of epilepsy;
- Unstable or progressive medical conditions (e.g., cancer);
- Psychosis according to DSM-5 criteria;
- Presence of another pain condition more severe than the one qualifying for inclusion;
- Failure to correctly complete pain self-assessment diaries between inclusion and randomization (fewer than 4 pain scores recorded over 7 days);
- Inability to understand the informed consent form, or subjects under legal guardianship or curatorship;
- Participation in another research protocol within 30 days prior to inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle
Boulogne-Billancourt, Île-de-France Region, 92100
Nadine ATTAL, +33 1 49 09 59 31, nadine.attal@aphp.fr
About this study
Official title: Analgesic Efficacy of Multisite rTMS in Depressed and Nondepressed Patients With Fibromyalgia and Prediction of the Response: a Double-Blind Randomized Sham-Controlled Study.
Repetitive Transcranial Magnetic Stimulation (rTMS) of the motor cortex is a recognized analgesic technique for the treatment of fibromyalgia pain, which represents a largely unmet medical need. However, the effectiveness of motor cortex rTMS is inconsistent, being observed in only about 40% of patients and not always long-lasting. It has been previously shown that predictive factors for a lack of response to motor cortex rTMS include the presence of depressive symptoms, and that prefrontal cortex rTMS is not effective for pain, even though this treatment has proven efficacy in major depressive disorder.
The hypothesis is that targeting both the motor and prefrontal cortices with rTMS will yield a particularly beneficial effect in fibromyalgia patients presenting with comorbid depressive symptoms.
Given the absence of established biomarkers for predicting rTMS response, an additional aim will be to develop reliable indicators of rTMS efficacy, based on clinical phenotype and measurements of oscillatory patterns assessed by electroencephalogram (EEG) recordings.
Read the detailed description
This is a monocentric, randomized, double-blind, parallel-group, sham-controlled trial. After providing informed consent, patients will first undergo brain magnetic resonance imaging (MRI) to determine the exact position of the coil for rTMS neuronavigation.
Clinical and psychological outcomes - assessed using validated self-report questionnaires - as well as neurophysiological parameters - including resting-state brain oscillatory activity (EEG) and cortical excitability measures (TMS and electromyography) - will be recorded at three time points: (i) at inclusion, approximately one week before treatment initiation; (ii) after completion of the 5-day intensive stimulation phase; and (iii) at the follow-up visit, two weeks after the end of treatment.
Correlations between the analgesic effects of active or sham rTMS and changes in clinical and electrophysiological parameters will be evaluated.
The treatment consists of 5 daily sessions of high-frequency rTMS of the motor and prefrontal cortex (one 30-minute session per day delivering 3000 pulses). This will be followed by: one session per week for the following 3 weeks; one session every 15 days during the following month.
This results in a total of 10 sessions over approximately 2 months.
- Being tested
- rTMS, Sham
- Keywords
- Fibromyalgia, Chronic Pain, rTMS, Depression, Neuromodulation, EEG
- Medical subject headings
- Fibromyalgia, Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
The active protocol will include 5 daily stimulation sessions during the first week (D1-D5), followed by one session per week for 3 weeks (W2, W3, W4), then 2 sessions spaced 2 weeks apart (W6, W8), for a total of 10 stimulation sessions. Evaluation will continue until 2 weeks after the final stimulation, that is, at week 10 after the start of treatment.
ShamDevice
The sham protocol will follow an identical session schedule. Participants will be randomized to either the active or sham group in a parallel-group design, meaning each participant will receive only one of the two treatments throughout the entire duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS of motor and prefrontal cortex | Experimental | Each rTMS session for each cortical target will include 30 trains of pulses delivered at 10 Hz for 10 seconds (100 pulses per train), with a 20-second interval between each train, resulting in a total of 3,000 pulses per session. The total duration will be 15 to 20 minutes per target, and 30 to 40 minutes for both cortical targets combined.
The stimulation intensity for the left motor cortex will be set at 80% of the resting motor threshold, defined as the minimal stimulation intensity that induces an electromyographic response of ≥50 µV in the first dorsal interosseous muscle of the hand, contralateral to the stimulated hemisphere, in at least 5 out of 10 trials.
For stimulation of the left prefrontal cortex, we will use a stimulation intensity of 120% of the motor threshold, as is customary in psychiatry and as in our previous studies on analgesia (Attal et al., 2021). Receives: Device: rTMS |
| Sham rTMS of motor and prefrontal cortex | Sham comparator | To perform the rTMS, a figure-of-eight Cool-B65 A/P coil (MagVenture) will be used. This coil features a symmetrical design with two indistinguishable faces-one for active stimulation and the other for sham stimulation. The side used for each rTMS session will be determined by a personalized USB key for each patient, which will be connected to the rTMS device. The sound emitted during stimulation will be identical regardless of the side of the coil used.
Finally, to further strengthen the treatment blinding for both the patient and the operator, the scalp-tapping sensation induced by active rTMS will be mimicked by low-intensity electrical stimulation applied to the head via surface electrodes. This electrical stimulation will be synchronized with the magnetic pulses during both active and sham stimulation sessions. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average pain intensity over 10 weeks (Brief Pain Inventory)
The primary outcome measure will be the mean change from baseline over the course of 10 weeks (group x time interaction) in average pain intensity from the Brief Pain Inventory (scored on a 0-10 NRS with 0 = no pain and 10 = maximal pain intensity). Baseline average pain intensity will be assessed at inclusion, and just before the first rTMS session (Day 1) and will correspond to the average of these two values. Pain intensity will be further assessed immediately before each rTMS session at Days 2, 3, 4, 5 then at weeks 2, 3, 4, 6, 8, and finally 2 weeks after the last rTMS session at week 10.
Measured: From enrollment to Week 10.
Secondary outcomes (16)
Weekly pain, fatigue and sleep disturbances
Weekly average of daily patient-reported scores for pain intensity, fatigue, and sleep disturbance, recorded in a self-assessment diary completed throughout the study. Pain intensity and fatigue are each assessed on a numerical rating scale from 0 (no pain/no fatigue) to 10 (worst imaginable pain/worst imaginable fatigue), where higher scores indicate worse outcome. Sleep disturbance is assessed on a numerical rating scale from 0 (no interference) to 10 (completely disrupted sleep), where higher scores indicate worse outcome.
Measured: At each visit from baseline to Week 10.
Immediate effect of rTMS on pain intensity
Pain intensity at the present moment assessed immediately after each rTMS session using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: At each visit from baseline to Week 10.
Onset of the therapeutic effect
The time to onset of the therapeutic effect from the first stimulation, assessed by measuring 24-hour pain scores recorded in the patient's self-assessment diary.
Measured: At each visit from baseline to Week 10.
Brief Pain Inventory (BPI)
The validated French version of the BPI (Cleeland and Ryan, 1994) will be used to assess maximum and minimum pain over the past 24 hours and at the present moment, as well as the impact of pain (general activity, mood, ability to walk, usual work, relationships with others, sleep, quality of life), on numerical scales from 0 to 10.
Measured: From enrollment to Week 10.
Fibromyalgia Impact Questionnaire (FIQ)
A validated self-report questionnaire specifically designed to assess the impact of fibromyalgia on quality of life. Scores range from 0 to 100, where higher scores indicate greater impact of fibromyalgia on functioning and worse outcome.
Measured: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
EuroQol 5-Dimension health status questionnaire (EQ-5D-5L)
A self-report questionnaire assessing health-related quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-level scale from 1 (no problems) to 5 (extreme problems), where higher scores indicate worse outcome. A Visual Analogue Scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health) is also included, where higher scores indicate better outcome.
Measured: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Hospital Anxiety and Depression Scale (HADS)
A self-report questionnaire assessing the severity of anxiety and depressive symptoms over the past week. It consists of two 7-item subscales - one for anxiety (HADS-A) and one for depression (HADS-D) - each scored from 0 to 21, where higher scores indicate greater symptom severity.
Measured: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Patient Health Questionnaire (PHQ-9)
A validated 9-item self-report questionnaire assessing the presence and severity of depressive symptoms over the past two weeks. Total scores range from 0 to 27, where higher scores indicate greater severity of depressive symptoms.
Measured: At baseline, after 5 days of treatment, and at Week 10.
Pain Catastrophizing Scale (PCS)
A 13-item self-report questionnaire assessing the tendency to magnify, ruminate, and feel helpless in response to pain. Each item is scored from 0 (not at all) to 4 (all the time), with a total score ranging from 0 to 52, where higher scores indicate greater catastrophizing.
Measured: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Medical Outcome Study Sleep Scale (MOS)
A 12-item self-report questionnaire assessing the main dimensions of sleep quality, commonly used in chronic pain syndromes. Each item is rated on a 6-point categorical scale from 1 (all the time) to 6 (never). Scores are converted to a Sleep Problems Index ranging from 0 to 100, where higher scores indicate greater sleep disturbance.
Measured: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Short-Form McGill Pain Questionnaire (SF-MPQ)
A 15-item self-report questionnaire assessing the sensory and affective dimensions of pain. Eleven items evaluate the sensory dimension and 4 items evaluate the affective dimension, each rated on a scale from 0 (none) to 3 (severe). Total scores range from 0 to 45, where higher scores indicate greater pain intensity.
Measured: At the inclusion visit, baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Blinding Assessment Questionnaire
A validated questionnaire administered at the end of the study to assess the integrity of blinding. Participants are asked which treatment they believe they received (active, sham, or unsure) and the reasons for their belief (side effects, symptom relief, or other).
Measured: At Week 10.
Patient and examiner's global clinical impression (PGIC, CGIC)
Single-item scales assessing the patient's and clinician's overall impression of change since the beginning of treatment, respectively. Both are rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicate worse outcome.
Measured: From Week 2 to Week 10.
Credibility/expectancy questionnaire (CEQ)
A validated self-report questionnaire administered prior to treatment initiation to assess patients' beliefs about the credibility of the assigned treatment and their expectations regarding its therapeutic outcome. The first four items (Set 1), evaluating the cognitive dimensions of credibility and expectancy, will be used. Items are rated on a scale from 1 to 9, where higher scores indicate greater treatment credibility and expectancy.
Measured: At baseline and after the first week of treatment.
Treatment responders
The percentage of treatment responders (patients whose pain is reduced by at least 30% and 50%) at the end of treatment.
Measured: At Week 10.
Incidence of Treatment-Emergent Adverse Events
The safety and tolerability of the treatment, assessed by asking patients about any side effects experienced during the rTMS sessions.
Measured: At each visit from baseline to Week 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642882
- Sponsor's protocol ID
- 2025-A01369-40
- Acronym
- MultiStimFM
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data has not yet been determined.
Publications
Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Dec 16;144(11):3328-3339. doi: 10.1093/brain/awab208.
PubMed 34196698Lapa JDDS, da Silva VA, Ciampi de Andrade D. Repetitive transcranial magnetic stimulation for fibromyalgia: are we there yet? Pain Rep. 2025 Jan 13;10(1):e1221. doi: 10.1097/PR9.0000000000001221. eCollection 2025 Feb.
PubMed 39816903Ciampi de Andrade D, Valiengo L. Differential Effects of Repetitive Transcranial Magnetic Stimulation on Mood and Pain Symptoms in People With Chronic Pain and Major Depressive Disorders-A Review. Eur J Pain. 2025 Aug;29(7):e70077. doi: 10.1002/ejp.70077.
PubMed 40693547Silva VA, Baptista AF, Fonseca AS, Carneiro AM, Brunoni AR, Carrilho PEM, Lins CC, Kubota GT, Fernandes AMBL, Lapa JDS, Dos Santos LM, Sasso I, Monte-Silva K, Poindessous-Jazat F, Mori N, Miki K, Baltar A, Tanaka C, Teixeira MJ, Hosomi K, Bouhassira D, Attal N, Ciampi de Andrade D. Motor cortex repetitive transcranial magnetic stimulation in fibromyalgia: a multicentre randomised controlled trial. Br J Anaesth. 2025 Jun;134(6):1756-1764. doi: 10.1016/j.bja.2024.12.045. Epub 2025 Mar 13.
PubMed 40087077Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.
PubMed 17872930Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
PubMed 21397400
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Multisite rTMS in Depressed and Nondepressed Patients With Fibromyalgia and Prediction of the Response: a Double-Blind Randomized Sham-Controlled Study.
- ClinicalTrials.gov ID
- NCT07642882
- Acronym / sponsor ID
- MultiStimFM / 2025-A01369-40
- Keywords
- Fibromyalgia, Chronic Pain, rTMS, Depression, Neuromodulation, EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 11 Jun 2026 (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.
Repetitive Transcranial Magnetic Stimulation (rTMS) of the motor cortex is a recognized analgesic technique for the treatment of fibromyalgia pain, which represents a largely unmet medical need. However, the effectiveness of motor cortex rTMS is inconsistent, being observed in only about 40% of patients and not always long-lasting. It has been previously shown that predictive factors for a lack of response to motor cortex rTMS include the presence of depressive symptoms, and that prefrontal cortex rTMS is not effective for pain, even though this treatment has proven efficacy in major depressive disorder.
The hypothesis is that targeting both the motor and prefrontal cortices with rTMS will yield a particularly beneficial effect in fibromyalgia patients presenting with comorbid depressive symptoms.
Given the absence of established biomarkers for predicting rTMS response, an additional aim will be to develop reliable indicators of rTMS efficacy, based on clinical phenotype and measurements of oscillatory patterns assessed by electroencephalogram (EEG) recordings.
Detailed description
This is a monocentric, randomized, double-blind, parallel-group, sham-controlled trial. After providing informed consent, patients will first undergo brain magnetic resonance imaging (MRI) to determine the exact position of the coil for rTMS neuronavigation.
Clinical and psychological outcomes - assessed using validated self-report questionnaires - as well as neurophysiological parameters - including resting-state brain oscillatory activity (EEG) and cortical excitability measures (TMS and electromyography) - will be recorded at three time points: (i) at inclusion, approximately one week before treatment initiation; (ii) after completion of the 5-day intensive stimulation phase; and (iii) at the follow-up visit, two weeks after the end of treatment.
Correlations between the analgesic effects of active or sham rTMS and changes in clinical and electrophysiological parameters will be evaluated.
The treatment consists of 5 daily sessions of high-frequency rTMS of the motor and prefrontal cortex (one 30-minute session per day delivering 3000 pulses). This will be followed by: one session per week for the following 3 weeks; one session every 15 days during the following month.
This results in a total of 10 sessions over approximately 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS of motor and prefrontal cortex | Experimental | Device: rTMSEach rTMS session for each cortical target will include 30 trains of pulses delivered at 10 Hz for 10 seconds (100 pulses per train), with a 20-second interval between each train, resulting in a total of 3,000 pulses per session. The total duration will be 15 to 20 minutes per target, and 30 to 40 minutes for both cortical targets combined. The stimulation intensity for the left motor cortex will be set at 80% of the resting motor threshold, defined as the minimal stimulation intensity that induces an electromyographic response of ≥50 µV in the first dorsal interosseous muscle of the hand, contralateral to the stimulated hemisphere, in at least 5 out of 10 trials. For stimulation of the left prefrontal cortex, we will use a stimulation intensity of 120% of the motor threshold, as is customary in psychiatry and as in our previous studies on analgesia (Attal et al., 2021). |
| Sham rTMS of motor and prefrontal cortex | Sham comparator | Device: ShamTo perform the rTMS, a figure-of-eight Cool-B65 A/P coil (MagVenture) will be used. This coil features a symmetrical design with two indistinguishable faces-one for active stimulation and the other for sham stimulation. The side used for each rTMS session will be determined by a personalized USB key for each patient, which will be connected to the rTMS device. The sound emitted during stimulation will be identical regardless of the side of the coil used. Finally, to further strengthen the treatment blinding for both the patient and the operator, the scalp-tapping sensation induced by active rTMS will be mimicked by low-intensity electrical stimulation applied to the head via surface electrodes. This electrical stimulation will be synchronized with the magnetic pulses during both active and sham stimulation sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chronic pain lasting at least 6 months, with or without associated depressive symptoms;
- Fibromyalgia (2016 revised ACR criteria and a FIRST questionnaire score of at least 5 out of 6);
- Average pain intensity ≥ 4/10 on a 0-10 numeric rating scale;
- Pain present daily or almost daily (≥ 4 days per week);
- Patients aged over 18 and under 80 years;
Key exclusion criteria (13 listed)
- Ongoing litigation;
- Contraindication to rTMS:
- Implanted electronic devices and/or conductive objects near the coil: Patients with an active implanted device that is activated or controlled by physiological signals (e.g., pacemakers, implantable cardiac defibrillators [ICD], vagus nerve stimulators [VNS], wearable cardioverter defibrillators [WCD], ocular implants, deep brain stimulation systems, drug infusion pumps or ports, intracardiac leads), even if the device has been removed.
- Non-removable metallic objects near the coil:** Patients with a conductive, ferromagnetic, or magnetically sensitive metal implant in the head or within 30 cm of the coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, or bullet fragments);
- Current abuse of drugs or psychoactive substances, including alcohol (according to DSM-5 criteria);
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 |
|---|---|---|
| rTMSThe active protocol will include 5 daily stimulation sessions during the first week (D1-D5), followed by one session per week for 3 weeks (W2, W3, W4), then 2 sessions spaced 2 weeks apart (W6, W8), for a total of 10 stimulation sessions. Evaluation will continue until 2 weeks after the final stimulation, that is, at week 10 after the start of treatment. | Device | Active rTMS of motor and prefrontal cortex |
| ShamThe sham protocol will follow an identical session schedule. Participants will be randomized to either the active or sham group in a parallel-group design, meaning each participant will receive only one of the two treatments throughout the entire duration of the study. | Device | Sham rTMS of motor and prefrontal cortex |
Primary outcome
Change in average pain intensity over 10 weeks (Brief Pain Inventory)
Time frame: From enrollment to Week 10.
The primary outcome measure will be the mean change from baseline over the course of 10 weeks (group x time interaction) in average pain intensity from the Brief Pain Inventory (scored on a 0-10 NRS with 0 = no pain and 10 = maximal pain intensity). Baseline average pain intensity will be assessed at inclusion, and just before the first rTMS session (Day 1) and will correspond to the average of these two values. Pain intensity will be further assessed immediately before each rTMS session at Days 2, 3, 4, 5 then at weeks 2, 3, 4, 6, 8, and finally 2 weeks after the last rTMS session at week 10.
16 secondary outcomes
Weekly pain, fatigue and sleep disturbances
Time frame: At each visit from baseline to Week 10.
Immediate effect of rTMS on pain intensity
Time frame: At each visit from baseline to Week 10.
Onset of the therapeutic effect
Time frame: At each visit from baseline to Week 10.
Brief Pain Inventory (BPI)
Time frame: From enrollment to Week 10.
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
EuroQol 5-Dimension health status questionnaire (EQ-5D-5L)
Time frame: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Patient Health Questionnaire (PHQ-9)
Time frame: At baseline, after 5 days of treatment, and at Week 10.
Pain Catastrophizing Scale (PCS)
Time frame: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Medical Outcome Study Sleep Scale (MOS)
Time frame: At baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: At the inclusion visit, baseline, after 5 days of treatment, at weeks 4, 6, 8 and 10.
Blinding Assessment Questionnaire
Time frame: At Week 10.
Patient and examiner's global clinical impression (PGIC, CGIC)
Time frame: From Week 2 to Week 10.
Credibility/expectancy questionnaire (CEQ)
Time frame: At baseline and after the first week of treatment.
Treatment responders
Time frame: At Week 10.
Incidence of Treatment-Emergent Adverse Events
Time frame: At each visit from baseline to Week 10.
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 11 Jun 2026.
- Background: PubMed 34196698Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Dec 16;144(11):3328-3339. doi: 10.1093/brain/awab208.
- Background: PubMed 39816903Lapa JDDS, da Silva VA, Ciampi de Andrade D. Repetitive transcranial magnetic stimulation for fibromyalgia: are we there yet? Pain Rep. 2025 Jan 13;10(1):e1221. doi: 10.1097/PR9.0000000000001221. eCollection 2025 Feb.
- Background: PubMed 40693547Ciampi de Andrade D, Valiengo L. Differential Effects of Repetitive Transcranial Magnetic Stimulation on Mood and Pain Symptoms in People With Chronic Pain and Major Depressive Disorders-A Review. Eur J Pain. 2025 Aug;29(7):e70077. doi: 10.1002/ejp.70077.
- Background: PubMed 40087077Silva VA, Baptista AF, Fonseca AS, Carneiro AM, Brunoni AR, Carrilho PEM, Lins CC, Kubota GT, Fernandes AMBL, Lapa JDS, Dos Santos LM, Sasso I, Monte-Silva K, Poindessous-Jazat F, Mori N, Miki K, Baltar A, Tanaka C, Teixeira MJ, Hosomi K, Bouhassira D, Attal N, Ciampi de Andrade D. Motor cortex repetitive transcranial magnetic stimulation in fibromyalgia: a multicentre randomised controlled trial. Br J Anaesth. 2025 Jun;134(6):1756-1764. doi: 10.1016/j.bja.2024.12.045. Epub 2025 Mar 13.
- Background: PubMed 17872930Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.
- Background: PubMed 21397400Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data has not yet been determined.
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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 and Depression - Major Depressive Disorder, run by Hospital Ambroise Paré Paris at 1 site in France.
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 13 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 11 Jun 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 France. 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. Some participants in this study may receive a placebo. 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 Nadine ATTAL (+33 1 49 09 59 31, nadine.attal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average pain intensity over 10 weeks (Brief Pain Inventory) (time frame: From enrollment to Week 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07642882, which also lists 6 linked publications.
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 11 Jun 2026.