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

February 15, 2021 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Boulogne-Billancourt, France
        • Recruiting
        • CHU Ambroise Pare
        • Contact:
          • Didier BOUHASSIRA
        • Principal Investigator:
          • Didier BOUHASSIRA
      • Clermont-Ferrand, France, 63003
      • Créteil, France
        • Recruiting
        • Hopital Henri Mondor
        • Contact:
          • Jean-Pascal Lefaucheur
        • Principal Investigator:
          • Jean-Pascal Lefaucheur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Other: 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Other: 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in "average pain" score on the brief pain inventory
Time Frame: 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.
at day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in "average pain" score on the brief pain inventory
Time Frame: at weekk 3 and 4
Variation of the average pain at several time-points during the 4 weeks follow-up
at weekk 3 and 4
Location of MRI abnormalities
Time Frame: at week 3 and 4
Correlation between pain and pain decrease with MRI abnormalities in several regions of interest
at week 3 and 4
Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF
Time Frame: at week 3 and 4
at week 3 and 4
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: at day 1
at day 1
change from baseline in specific questionnaires
Time Frame: at day 8, week 3 and 4
at day 8, week 3 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Xavier MOISSET, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2014

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0179
  • 2013-A01422-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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