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Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS-rTMS | Experimental | subjects receiving real rTMS treatment and real rTMS maintenance sessions |
|
| sham - sham | Sham Comparator | subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions |
|
| rTMS-sham | Sham Comparator | subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment |
|
| rTMS | Experimental | real rTMS for 3 weeks but without clinical improvement |
|
| sham | Sham Comparator | sham treatment for 3 weeks without clinical improvement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 210 days |
| Measure | Description | Time Frame |
|---|---|---|
| number of rTMS responders at 3week-rTMS treatment | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Christophe Dumont, MD | CHU Dupuytren CH Esquirol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Esquirol | Limoges | 87000 | France | |||
| Centre Hospitalier Universitaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23673085 | Background | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| sham rTMS | Device | same session as defined with the real rTMS, but with a coil not delivering magnetic field. |
|
| Limoges |
| 87000 |
| France |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |