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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00065-44 | Other Identifier | ANSM |
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The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS then sham rTMS | Experimental | Active rTMS in 1st period and sham rTMS in 2nd period |
|
| Sham rTMS then active rTMS | Experimental | Sham rTMS in 1st period and active rTMS in 2nd period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active rTMS then sham rTMS | Device | A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ") | Percentage of pain relief compared to the beginning of the period of the study before the first stimulation | 3 weeks later the last session of rTMS (active ) so week n°12 |
| Percentage of pain relief (0%= " no pain relief " and 100% " complete pain | Percentage of pain relief compared to the beginning of the period of the study before the first stimulation | 3 weeks later the last session of rTMS (sham) so week n°29. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable "). | 3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29. | |
| Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland PEYRON, MD PhD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| sham rTMS then active rTMS | Device | A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months |
|
| before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29) |
| Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29) | before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29) |
| Neuropathic dimension | specific paper questionnaire of neuropathic pain NPSI at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29) | at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29) |
| - Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%. | at the end of each period of 4 sessions (weeks n°12 and 29) |
| Consumption of analgesic treatment | 3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |