FibromyalgiaNCT00697398
Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
A study testing Transcranial stimulation in people with Fibromyalgia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Transcranial stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Oct 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patient, aged from 18 to 65 years
- Patient presenting a primary fibromyalgia answering the criteria of the ACR
- At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10
- Patient presenting a stable treatment since at least 1 less
Who cannot join
- Patient minor
- pregnant woman
- women in age to procreate without contraception
- patient deprived of freedom further to a court or administrative order
- patient presenting a secondary fibromyalgia
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire
Marseille, 13385
About this study
Official title: Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.
Read the detailed description
We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.
- Conditions
- Fibromyalgia
- Being tested
- Transcranial stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial stimulationOther
Stimulation to white
Transcranial stimulationOther
Repetitive transcranial magnetic stimulation (rTMS)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Sound placebo Receives: Other: Transcranial stimulation |
| 2 | Experimental | Sound Receives: Other: Transcranial stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficiency
Measured: 36 months
Secondary outcomes (3)
Additional evaluation of the pain
Measured: 36 months
Evaluation of the quality of life
Measured: 36 months
Evaluation of the tolerance of the treatment
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2011
- Study completionOct 2011
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.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Guedj, MD, Principal investigator, Assistance Publique des hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697398
- Sponsor's protocol ID
- 2008-A00084-51
- Other IDs
- 2008-01
- Status last verified
- Jan 2010
- First submitted
- 9 Jun 2008
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Boyer L, Dousset A, Roussel P, Dossetto N, Cammilleri S, Piano V, Khalfa S, Mundler O, Donnet A, Guedj E. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. Neurology. 2014 Apr 8;82(14):1231-8. doi: 10.1212/WNL.0000000000000280. Epub 2014 Mar 26.
PubMed 24670891
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
- ClinicalTrials.gov ID
- NCT00697398
- Acronym / sponsor ID
- 2008-A00084-51
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Jun 2008 (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.
Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.
Detailed description
We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Transcranial stimulationSound placebo |
| 2 | Experimental | Other: Transcranial stimulationSound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male patient, aged from 18 to 65 years
- Patient presenting a primary fibromyalgia answering the criteria of the ACR
- At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10
- Patient presenting a stable treatment since at least 1 less
Key exclusion criteria (5 listed)
- Patient minor
- pregnant woman
- women in age to procreate without contraception
- patient deprived of freedom further to a court or administrative order
- patient presenting a secondary fibromyalgia
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 |
|---|---|---|
| Transcranial stimulationStimulation to white | Other | 1 |
| Transcranial stimulationRepetitive transcranial magnetic stimulation (rTMS) | Other | 2 |
Primary outcome
Analgesic efficiency
Time frame: 36 months
3 secondary outcomes
Additional evaluation of the pain
Time frame: 36 months
Evaluation of the quality of life
Time frame: 36 months
Evaluation of the tolerance of the treatment
Time frame: 36 months
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 28 Aug 2014.
- Derived from this study: PubMed 24670891Boyer L, Dousset A, Roussel P, Dossetto N, Cammilleri S, Piano V, Khalfa S, Mundler O, Donnet A, Guedj E. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. Neurology. 2014 Apr 8;82(14):1231-8. doi: 10.1212/WNL.0000000000000280. Epub 2014 Mar 26.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Eric Guedj, MD principal investigator
Assistance Publique des hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial stimulation in people with Fibromyalgia, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 5 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 28 Aug 2014. 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?
Analgesic efficiency (time frame: 36 months). 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 NCT00697398, 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 28 Aug 2014.