Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
- Conditions
- Multiple Sclerosis With Central Neuropathic Pain
- Interventions
- Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
- Registration Number
- NCT02059096
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 66
- relapsing-remitting Multiple Sclerosis
- 18 to 60 years
- central neuropathic pain with a DN4 score of 4 or more out of 10
- average pain of at least 4/10
- presence of pain at least 4 days per week
- presence of pain for at least 3 months
- stable analgesic treatment
- relapse during the previous 30 days
- contraindication for rTMS
- peripheral neuropathic pain
- severe depression
- epilepsia
- resting motor threshold above 75%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Theta-Burst Stimulation (pcTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) 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 Repetitive Transcranial Magnetic Stimulation (rTMS) 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) Repetitive Transcranial Magnetic Stimulation (rTMS) 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
- Primary Outcome Measures
Name Time Method Change from baseline in "average pain" score on the brief pain inventory at day 8 Variation of the "Average pain" score on the Brief Pain Inventory between before treatment (on a 7 days period) and day 8.
- Secondary Outcome Measures
Name Time Method Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF at week 3 and 4 change from baseline in "average pain" score on the brief pain inventory at weekk 3 and 4 Variation of the average pain at several time-points during the 4 weeks follow-up
Location of MRI abnormalities at week 3 and 4 Correlation between pain and pain decrease with MRI abnormalities in several regions of interest
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
Trial Locations
- Locations (3)
CHU Ambroise Paré
🇫🇷Boulogne-Billancourt, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Hôpital Henri Mondor
🇫🇷Créteil, France