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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01422-43 |
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This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin.
On the one hand, Multiple Sclerosis (MS) is the most frequent chronic disease generating neurological disability in young adults. Among the many types of disabilities associated with MS, chronic pain is very frequent, especially neuropathic pain. This type of pain is often treatment resistant. Moreover, abnormal intra-cortical excitability has been described in MS patients.
On the other hand, repetitive Transcranial Magnetic Stimulation (rTMS) has shown an analgesic effect in various chronic pain conditions (fibromyalgia, post-stroke, peripheral neuropathic pain). Three groups have shown that analgesia was correlated to defective intra-cortical excitability restoration.
The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation.
Patients will benefit from 1 daily session per day for 5 consecutive days and from a total follow up of 4 weeks. Pain will be assessed each day and several other signs and symptoms will be repeatedly assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) | Experimental | The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation |
|
| Theta-Burst Stimulation (pcTBS) | Other | The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation. |
|
| repetitive Transcranial Magnetic Stimulation (rTMS)placebo | Other | The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in "average pain" score on the brief pain inventory | Variation of the "Average pain" score on the Brief Pain Inventory between before treatment (on a 7 days period) and day 8. | at day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in "average pain" score on the brief pain inventory | Variation of the average pain at several time-points during the 4 weeks follow-up | at weekk 3 and 4 |
| Location of MRI abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | 04 73 75 4963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier MOISSET | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Ambroise Paré | Recruiting | Boulogne-Billancourt | France |
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Correlation between pain and pain decrease with MRI abnormalities in several regions of interest
| at week 3 and 4 |
| Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF | at week 3 and 4 |
| Number of participants with adverse events as a measure of safety and tolerability | at day 1 |
| change from baseline in specific questionnaires | at day 8, week 3 and 4 |
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
|
| Hôpital Henri Mondor | Recruiting | Créteil | France |
|
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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