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The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:
Conduct of study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classic rTMS Stimulation using the B65 Coil | Experimental |
| |
| Deeper rTMS Stimulation using the B70 Coil | Experimental |
| |
| control group with a sham stimulation using a sham coil | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RepetitiveTranscranial Magnetic Stimulation (rTMS) | Device | The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of Pain. | Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better). | Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS | Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI). | Day 60 from the beginning of rTMS treatment compared to baseline. |
| Rate of Responding Patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasan HODAJ, MD | Contact | 04-76-76-52-13 | 33 | HHodaj@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hasan HODAJ, MD | CHUGA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de la douleur, CHU Grenoble Alpes | Recruiting | Grenoble | Isère | 38043 | France |
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Comparison between the 3 groups of the rate of responding patients. Responding patients is defined by a 30% reduction in pain intensity assessed with VNS. |
| week 7 compared with baseline |
| Assessment of Overall Patient Improvement. | Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse). | Day 30 and day 60 from the beginning of rTMS treatment compared to baseline |
| Quality of Life Improvement. | Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire.SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life. | Day 30 and day 60 from the beginning of rTMS treatment compared to baseline |
| Evolution of Anxiety and Depressive Traits. | Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score. | Day 30 and day 60 from the beginning of rTMS treatment compared to baseline |
| Evolution of Symptomatological Profiles of Neuropathic Pain. | Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory). | Day 30 and day 60 from the beginning of rTMS treatment compared to baseline. |
| Sympathetic Autonomic System Injury and Small Fiber Neuropathy. | Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device. | Day 60 from the beginning of rTMS treatment compared to baseline. |
| Autonomous System Assessement. | Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination. | Day 60 from the beginning of rTMS treatment compared to baseline. |
| Evolution of the use of analgesic treatments. | Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary. | From baseline to day 60. |
| Analgesic Response Analysis | Comparison between the 3 groups of the evolution of the weekly EVN average according to the clinical profile of patients | From baseline to day 60. |
| Improvement of pain triggered by a stimulus (allodynia). | Comparison between the 3 groups of allodynia improvement. | Day 30 and day 60 from the beginning of rTMS treatment compared to baseline. |