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This study will investigate the efficacy and safety of "deep" rTMS on neuropathic pain or fibromyalgia. It will be randomized and sham controlled and will last 3 months. Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions (5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks).
This double blind sham controlled parallel group bicenter study will assess the efficacy and safety of repeated sessions of deep rTMS using H coil in patients with neuropathic pain or fibromyalgia. Primary outcome will be % of pain relief at week 13.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | Deep rTMS with H coil targeting the motor cortex bilaterally |
|
| Sham rTMS | Placebo Comparator | Sham rTMS with H coil targeting the motor cortex bilaterally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep active rTMS with Hesed coil | Device | This brain neurostimulation method targets the motor cortex bilaterally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of rTMS versus sham rTMS on pain relief at 13 weeks | Pain relief scale from the Brief Pain Inventory rated from 0 to 100 % | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of rTMS vs sham on average pain intensity | Average pain intensity from the Brief Pain Inventory rated from 0 to 10 on a 0-10 numerical pain scale | Each follow up visit at the pain center for up to 13 weeks |
| Effects of rTMS vs sham on pain interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadine ATTAL | Contact | 0033149095931 | nadine.attal@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nadine ATTAL | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inserm U987 | Recruiting | Boulogne-Billancourt | 92100 | France |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| Sham rTMS with Hesed coil | Device | This brain sham neurostimulation method targets the motor cortex bilaterally |
|
pain interference from Brief Pain Inventory rated from 0 to 70 (total score) |
| Baseline then each follow up visit at the pain center for up to 13 weeks |
| Effects of rTMS vs sham on quality of life | Euroqol scale which includes 5 dimensions of quality of life and a 0-100 visual analog scale | Baseline then each follow up vist at the pain center for up to 13 weeks |
| Side effects of rTMS or sham | Any side effects reported by the patients assessed at each visit after each treatment session and rated as mild, moderate or severe | Each follow up visit at the pain center for up to 13 weeks |
| Comparison of the efficacy of rTMS on the primary outcome between patients with neuropathic pain and fibromyalgia | Comparison of both populations on the pain relief scale from the Brief Pain Inventory (0-100 %) | Week 13 |
| Blinding assessment | Blindinq questionnaire at 13 weeks(end of the study) | 13 weeks |
| Patient global impression of change | Patient global impression of change at 13 weeks (from much improved to much deteriorated) | 13 weeks |
| Self-reported pain intensity | Average pain intensity from past 24 hours based on 0-10 numerical pain scale | Baseline then every day at the same time of day (morning or evening) |
| Effects of rTMS versus sham on anxiety and depressive symptoms | Anxiety and depressive symptoms of the Hospital Anxiety and Depressive scale rated from 0 to 21 for anxiety and 0 to 21 for depression | Baseline then each follow up visit at the pain center for up to 13 weeks |
| Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory | pain intensity on 0-10 numerical rating scale | Baseline then each follow up visit at the pain center for up to 13 weeks |
| Effects of rTMS vs sham on pain as its least from Brief Pain Inventory | pain intensiy on 0-10 numerical rating scale | Baseline then each follow up visit at the pain center for up to 13 weeks |
| Effects of rTMS vs sham on sleep | Sleep assessed using the sleep scale from the Medical Outcome Survey | Baseline then each follow up visit at the pain center for up to 13 weeks |
| Effects of rTMS vs sham on pain right now from Brief Pain Inventory | pain intensiy on 0-10 numerical rating scale | Baseline then each follow up visit at the pain center for up to 13 weeks |
| Effects on Global Impression of change assessed by the clinician | Clinician global impression of change (from much improved to much deteriorated) | 13 weeks (end of the treatment) |
| Centre d'Evaluation et de Traitement de la douleur | Not yet recruiting | Paris | 75014 | France |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |