Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis (STIMASEP)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 3

Conditions: Multiple Sclerosis With Central Neuropathic Pain

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02059096

2013-A01422-43

CHU-0179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Repetitive transcranial magnetic stimulation (rTMS)

Experimental group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Theta-Burst Stimulation (pcTBS)

Other group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

repetitive Transcranial Magnetic Stimulation (rTMS)placebo

Other group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)