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

NCT ID: NCT02059096

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-05

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis With Central Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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repetitive Transcranial Magnetic Stimulation (rTMS)placebo

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.

Group Type OTHER

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Theta-Burst Stimulation (pcTBS)

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.

Group Type OTHER

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Interventions

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Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier MOISSET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Ambroise Paré

Boulogne-Billancourt, , France

Site Status RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise LACLAUTRE

Role: CONTACT

04 73 75 4963

Facility Contacts

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Didier BOUHASSIRA

Role: primary

Lise Laclautre

Role: primary

04 73 75 4963

Jean-Pascal Lefaucheur

Role: primary

Other Identifiers

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2013-A01422-43

Identifier Type: -

Identifier Source: secondary_id

CHU-0179

Identifier Type: -

Identifier Source: org_study_id

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