FibromyalgiaSTIMALGINCT01308801
Repetitive Transcranial Magnetic Stimulation in Fibromyalgia
A study testing active rTMS + rehabilitation exercise in people with Fibromyalgia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- active rTMS + rehabilitation exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary fibromyalgia according to the American College of Rheumatology
- no contraindication to rehabilitation exercise
- pain with VAS > 4 during at least six months
- FIQ score > 50
- no change in drug therapy over the last month
- affiliation to French Health Service
Who cannot join
- BMI > 35kg/m²
- patient who has already benefited from rTMS
- rTMS contraindication
- restless legs symptom
- patient suffering from major depression
- patient suffering from inflammatory rheumatism, autoimmune disease, other chronic pain pathology
Show all 9Show fewer
- sleep apnea syndrome
- no contraindication to rTMS or MRI
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia
The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia.
A double blind clinical trial with two randomized parallel groups:
- Placebo rTMS and rehabilitation exercise
- Active rTMS and rehabilitation exercise
Read the detailed description
Fibromyalgia is the most frequent chronic diffuse painful disease (3 to 4% of the general population).
Analgesic drugs are widely used in fibromyalgia, pain being the main symptom. However the effectiveness of analgesic drugs is often insufficient.
Among non-drug therapies, rehabilitation exercise plays an important role with a special interest in terms of the quality of life, strain and pain.
More recently the Transcranial Magnetic Stimulation effects have been evaluated in patients suffering from fibromyalgia with a statistically significative analgesic effect.
Both rehabilitation exercise and Transcranial Magnetic Stimulation (rTMS) have shown their respective analgesic effectiveness in fibromyalgia. It now seems important to evaluate the combination of these two therapies.
Main objective: To evaluate the analgesic effect of rTMS in fibromyalgia patients doing rehabilitation exercise.
Primary endpoint:
The evaluation methode used is a visual analog scale (VAS) of pain. Patients will note down every day VAS of over the last 24 hours.
The evolution of the VAS during the treatment period with respect to baseline, will be compared in both groups, active rTMS and placebo rTMS.
The investigators will analyze the average daily VAS for different weeks (W2, W4, W8, W14) compared to the average daily VAS at the baseline.
After a baseline period of 15 days, patients will begin sessions of rTMS and rehabilitation exercise for a period of 14 weeks.
The study is composed of three assessment visits : a baseline visit, a visit corresponding to the end of the therapy with exercise period and a last assessment visit at 26 weeks after the end of the treatment.
These visits will include clinical examination, blood test, an effort test, an orthostatic test, a resistance to fatigue test and polysomnography.
- Conditions
- Fibromyalgia
- Being tested
- active rTMS + rehabilitation exercise, placebo rTMS+ rehabilitation exercise
- Keywords
- fibromyalgia, pain, repetitive transcranial magnetic stimulation, rehabilitation exercise, quality of life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMS + rehabilitation exerciseDevice
14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
placebo rTMS+ rehabilitation exerciseDevice
14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
| Study group | Role | What they receive |
|---|---|---|
| active rTMS + rehabilitation exercise | Experimental | 14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise Receives: Device: active rTMS + rehabilitation exercise |
| placebo rTMS + rehabilitation exercise | Placebo comparator | 14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise Receives: Device: placebo rTMS+ rehabilitation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment
Patient will note down each day the VAS for the last 24 hours.
Measured: Daily average VAS at baseline, week 2, week 4, week 8, week 14
Secondary outcomes (7)
Change from base line in quality of life at 14 weeks and 26 weeks
Fibromyalgia Impact Questionnaire (FIQ)
Measured: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from base line in depression assessment at 14 weeks and 26 weeks
Beck Depression Inventory (BDI)
Measured: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in Covi's anxiety scale
Covi's anxiety scale
Measured: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in sleep quality at 14 weeks abd 26 weeks
Number of times awaking at night
Measured: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks
Maximal voluntary activation level
Measured: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in cardiac variability at 14 weeks and 26 weeks
RMSSD values, power of spectral density HF, KF, LF/HF, alpha index (baroreflex sensitivity)
Measured: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Evolution of the analgesic effect after the end of the program
Patient will note down each day the VAS for the last 24 hours.
Measured: Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Caroline Maindet-Dominici, MD, Principal investigator, Centre de la Douleur CHU de Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308801
- Sponsor's protocol ID
- 2010-A00865-34
- Acronym
- STIMALGI
- Status last verified
- Jan 2016
- First submitted
- 17 Dec 2010
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Burckhardt CS, Clark SR, Bennett RM. Fibromyalgia and quality of life: a comparative analysis. J Rheumatol. 1993 Mar;20(3):475-9.
PubMed 8478854Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1.
PubMed 18464301Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.
PubMed 17943797Cook DB, Nagelkirk PR, Poluri A, Mores J, Natelson BH. The influence of aerobic fitness and fibromyalgia on cardiorespiratory and perceptual responses to exercise in patients with chronic fatigue syndrome. Arthritis Rheum. 2006 Oct;54(10):3351-62. doi: 10.1002/art.22124.
PubMed 17009309Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. doi: 10.1016/s0987-7053(00)00240-9. French.
PubMed 11281066Passard 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 17872930Guinot M, Maindet C, Hodaj H, Hodaj E, Bachasson D, Baillieul S, Cracowski JL, Launois S. Effects of Repetitive Transcranial Magnetic Stimulation and Multicomponent Therapy in Patients With Fibromyalgia: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Mar;73(3):449-458. doi: 10.1002/acr.24118.
PubMed 31785190
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia
- ClinicalTrials.gov ID
- NCT01308801
- Acronym / sponsor ID
- STIMALGI / 2010-A00865-34
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, pain, repetitive transcranial magnetic stimulation, rehabilitation exercise, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- Apr 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Mar 2011 (estimated)
- 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 purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia.
A double blind clinical trial with two randomized parallel groups:
- Placebo rTMS and rehabilitation exercise
- Active rTMS and rehabilitation exercise
Detailed description
Fibromyalgia is the most frequent chronic diffuse painful disease (3 to 4% of the general population).
Analgesic drugs are widely used in fibromyalgia, pain being the main symptom. However the effectiveness of analgesic drugs is often insufficient.
Among non-drug therapies, rehabilitation exercise plays an important role with a special interest in terms of the quality of life, strain and pain.
More recently the Transcranial Magnetic Stimulation effects have been evaluated in patients suffering from fibromyalgia with a statistically significative analgesic effect.
Both rehabilitation exercise and Transcranial Magnetic Stimulation (rTMS) have shown their respective analgesic effectiveness in fibromyalgia. It now seems important to evaluate the combination of these two therapies.
Main objective: To evaluate the analgesic effect of rTMS in fibromyalgia patients doing rehabilitation exercise.
Primary endpoint:
The evaluation methode used is a visual analog scale (VAS) of pain. Patients will note down every day VAS of over the last 24 hours.
The evolution of the VAS during the treatment period with respect to baseline, will be compared in both groups, active rTMS and placebo rTMS.
The investigators will analyze the average daily VAS for different weeks (W2, W4, W8, W14) compared to the average daily VAS at the baseline.
After a baseline period of 15 days, patients will begin sessions of rTMS and rehabilitation exercise for a period of 14 weeks.
The study is composed of three assessment visits : a baseline visit, a visit corresponding to the end of the therapy with exercise period and a last assessment visit at 26 weeks after the end of the treatment.
These visits will include clinical examination, blood test, an effort test, an orthostatic test, a resistance to fatigue test and polysomnography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS + rehabilitation exercise | Experimental | Device: active rTMS + rehabilitation exercise14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise |
| placebo rTMS + rehabilitation exercise | Placebo comparator | Device: placebo rTMS+ rehabilitation exercise14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- primary fibromyalgia according to the American College of Rheumatology
- no contraindication to rehabilitation exercise
- pain with VAS > 4 during at least six months
- FIQ score > 50
- no change in drug therapy over the last month
Key exclusion criteria (9 listed)
- BMI > 35kg/m²
- patient who has already benefited from rTMS
- rTMS contraindication
- restless legs symptom
- patient suffering from major depression
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 |
|---|---|---|
| active rTMS + rehabilitation exercise14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise | Device | active rTMS + rehabilitation exercise |
| placebo rTMS+ rehabilitation exercise14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise | Device | placebo rTMS + rehabilitation exercise |
Primary outcome
Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment
Time frame: Daily average VAS at baseline, week 2, week 4, week 8, week 14
Patient will note down each day the VAS for the last 24 hours.
7 secondary outcomes
Change from base line in quality of life at 14 weeks and 26 weeks
Time frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from base line in depression assessment at 14 weeks and 26 weeks
Time frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in Covi's anxiety scale
Time frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in sleep quality at 14 weeks abd 26 weeks
Time frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks
Time frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Change from baseline in cardiac variability at 14 weeks and 26 weeks
Time frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program
Evolution of the analgesic effect after the end of the program
Time frame: Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 8478854Burckhardt CS, Clark SR, Bennett RM. Fibromyalgia and quality of life: a comparative analysis. J Rheumatol. 1993 Mar;20(3):475-9.
- Background: PubMed 18464301Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1.
- Background: PubMed 17943797Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.
- Background: PubMed 17009309Cook DB, Nagelkirk PR, Poluri A, Mores J, Natelson BH. The influence of aerobic fitness and fibromyalgia on cardiorespiratory and perceptual responses to exercise in patients with chronic fatigue syndrome. Arthritis Rheum. 2006 Oct;54(10):3351-62. doi: 10.1002/art.22124.
- Background: PubMed 11281066Dauvilliers Y, Touchon J. [Sleep in fibromyalgia: review of clinical and polysomnographic data]. Neurophysiol Clin. 2001 Feb;31(1):18-33. doi: 10.1016/s0987-7053(00)00240-9. French.
- 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.
- Results publication: PubMed 31785190Guinot M, Maindet C, Hodaj H, Hodaj E, Bachasson D, Baillieul S, Cracowski JL, Launois S. Effects of Repetitive Transcranial Magnetic Stimulation and Multicomponent Therapy in Patients With Fibromyalgia: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Mar;73(3):449-458. doi: 10.1002/acr.24118.
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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. This study is not recruiting at the moment.
Caroline Maindet-Dominici, MD principal investigator
Centre de la Douleur CHU de Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS + rehabilitation exercise in people with Fibromyalgia, run by University Hospital, Grenoble 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 17 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment (time frame: Daily average VAS at baseline, week 2, week 4, week 8, week 14). 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 NCT01308801, which also lists 7 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 17 Dec 2025.