Clinical trial NCT02059096: Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
Official title: Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Sclerosis With Central Neuropathic Pain
Keywords: Multiple Sclerosis
Repetitive transcranial magnetic stimulation (rTMS)
Chronic neuropathic pain
Cortical excitability
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Change from baseline in "average pain" score on the brief pain inventory
timeFrame: at day 8
Secondary outcomes:
measure: change from baseline in "average pain" score on the brief pain inventory
timeFrame: at weekk 3 and 4
measure: Location of MRI abnormalities
timeFrame: at week 3 and 4
measure: Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF
timeFrame: at week 3 and 4
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: at day 1
measure: change from baseline in specific questionnaires
timeFrame: at day 8, week 3 and 4
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: Hôpital Henri Mondor
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Xavier MOISSET
role: PRINCIPAL_INVESTIGATOR
References: