Multiple Sclerosis With Central Neuropathic Pain
Conditions
Keywords
Multiple Sclerosis, Repetitive transcranial magnetic stimulation (rTMS), Chronic neuropathic pain, Cortical excitability
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* relapse during the previous 30 days * contraindication for rTMS * peripheral neuropathic pain * severe depression * epilepsia * resting motor threshold above 75%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed