FibromyalgiaNCT01942538
Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia
A study testing rTMS in people with Fibromyalgia, run by Centre Hospitalier Esquirol at 2 sites in France.
Trial summary
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- 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
- 78 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2013to 28 Jul 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis,
- painful state for more than six months,
- visual analogic scale evaluation > or = 5,
- age between 18 and 70,
- no modification in therapeutic treatment one month before and during the protocol
- presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic
- residence in Limoges or the periphery, or the ability to come to the hospital for the treatment
Who cannot join
- presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble),
- active epilepsy,
- previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension,
- pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging.
- clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...),
- pregnancy, or administrative and judiciary protection, absence of health insurance.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Esquirol
Limoges, 87000
Centre Hospitalier Universitaire
Limoges, 87000
About this study
Official title: Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
Read the detailed description
In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a 40% improvement of pain feeling. Three months later, the pain level was still significantly reduced in comparison with the beginning of the treatment, but the clinical improvement was less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions at 3 weeks interval during 6 months with subjects presenting a significant clinical improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.
- Conditions
- Fibromyalgia
- Being tested
- rTMS, sham rTMS
- Keywords
- rTMS, fibromyalgia, sham, maintenance session, pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold
sham rTMSDevice
same session as defined with the real rTMS, but with a coil not delivering magnetic field.
| Study group | Role | What they receive |
|---|---|---|
| rTMS-rTMS | Experimental | subjects receiving real rTMS treatment and real rTMS maintenance sessions Receives: Device: rTMS |
| sham - sham | Sham comparator | subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions Receives: Device: sham rTMS |
| rTMS-sham | Sham comparator | subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment Receives: Device: rTMS; Device: sham rTMS |
| rTMS | Experimental | real rTMS for 3 weeks but without clinical improvement Receives: Device: rTMS |
| sham | Sham comparator | sham treatment for 3 weeks without clinical improvement Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
= number of fibromyalgia subjects maintaining a clinical improvement after a prior rTMS treatment (15 sessions in 3 weeks)and maintenance rTMS sessions administered at 42, 63, 84, 105, 126, 147, 168, 189, 210 days after inclusion in comparison with sham maintenance sessions.
clinical improvement is described as a 30% decrease from baseline in pain feeling (visual analogue scale) and a response ≥ 6 for the Patient's global impression of Change.
effect will be considered as maintained if criteria of clinical improvement present after 3 week rTMS treatment are conserved at 6 months rTMS or sham maintenance sessions.
Measured: 210 days
Secondary outcomes (1)
number of rTMS responders at 3week-rTMS treatment
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Christophe Dumont, Centre Hospitalier Esquirol
- Investigators
- Jean-Christophe Dumont, MD, Principal investigator, CHU Dupuytren CH Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942538
- Sponsor's protocol ID
- 2013-A00820-45
- Status last verified
- Feb 2019
- First submitted
- 11 Sep 2013
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ciobanu C, Girard M, Marin B, Labrunie A, Malauzat D. rTMS for pharmacoresistant major depression in the clinical setting of a psychiatric hospital: effectiveness and effects of age. J Affect Disord. 2013 Sep 5;150(2):677-81. doi: 10.1016/j.jad.2013.03.024. Epub 2013 May 11.
PubMed 23673085
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment
- ClinicalTrials.gov ID
- NCT01942538
- Acronym / sponsor ID
- 2013-A00820-45
- Conditions
- Fibromyalgia
- Keywords
- rTMS, fibromyalgia, sham, maintenance session, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 16 Sep 2013 (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.
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
Detailed description
In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a 40% improvement of pain feeling. Three months later, the pain level was still significantly reduced in comparison with the beginning of the treatment, but the clinical improvement was less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions at 3 weeks interval during 6 months with subjects presenting a significant clinical improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| rTMS-rTMS | Experimental | Device: rTMSsubjects receiving real rTMS treatment and real rTMS maintenance sessions |
| sham - sham | Sham comparator | Device: sham rTMSsubjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions |
| rTMS-sham | Sham comparator | Device: rTMS, Device: sham rTMSsubjects receiving sham rTMS maintenance sessions after successful real rTMS treatment |
| rTMS | Experimental | Device: rTMSreal rTMS for 3 weeks but without clinical improvement |
| sham | Sham comparator | Device: sham rTMSsham treatment for 3 weeks without clinical improvement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis,
- painful state for more than six months,
- visual analogic scale evaluation > or = 5,
- age between 18 and 70,
- no modification in therapeutic treatment one month before and during the protocol
Key exclusion criteria (6 listed)
- presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble),
- active epilepsy,
- previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension,
- pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging.
- clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...),
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 |
|---|---|---|
| rTMSone session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold | Device | rTMS, rTMS-rTMS, rTMS-sham |
| sham rTMSsame session as defined with the real rTMS, but with a coil not delivering magnetic field. | Device | rTMS-sham, sham, sham - sham |
Primary outcome
number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
Time frame: 210 days
= number of fibromyalgia subjects maintaining a clinical improvement after a prior rTMS treatment (15 sessions in 3 weeks)and maintenance rTMS sessions administered at 42, 63, 84, 105, 126, 147, 168, 189, 210 days after inclusion in comparison with sham maintenance sessions. clinical improvement is described as a 30% decrease from baseline in pain feeling (visual analogue scale) and a response ≥ 6 for the Patient's global impression of Change. effect will be considered as maintained if criteria of clinical improvement present after 3 week rTMS treatment are conserved at 6 months rTMS or sham maintenance sessions.
1 secondary outcome
number of rTMS responders at 3week-rTMS treatment
Time frame: 21 days
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 12 Feb 2019.
- Background: PubMed 23673085Ciobanu C, Girard M, Marin B, Labrunie A, Malauzat D. rTMS for pharmacoresistant major depression in the clinical setting of a psychiatric hospital: effectiveness and effects of age. J Affect Disord. 2013 Sep 5;150(2):677-81. doi: 10.1016/j.jad.2013.03.024. Epub 2013 May 11.
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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.
Jean-Christophe Dumont, MD principal investigator
CHU Dupuytren CH Esquirol
2 sites 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, run by Centre Hospitalier Esquirol at 2 sites 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 7 inclusion and 6 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months (time frame: 210 days). 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 NCT01942538, which also lists 1 linked publication.
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 12 Feb 2019.