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

Primary Purpose

Multiple Sclerosis With Central Neuropathic Pain

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis With Central Neuropathic Pain focused on measuring Multiple Sclerosis, Repetitive transcranial magnetic stimulation (rTMS), Chronic neuropathic pain, Cortical excitability

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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%

Sites / Locations

  • CHU Ambroise ParéRecruiting
  • CHU de Clermont-FerrandRecruiting
  • Hôpital Henri MondorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Repetitive transcranial magnetic stimulation (rTMS)

Theta-Burst Stimulation (pcTBS)

repetitive Transcranial Magnetic Stimulation (rTMS)placebo

Arm 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

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in "average pain" score on the brief pain inventory
Variation of the "Average pain" score on the Brief Pain Inventory between before treatment (on a 7 days period) and day 8.

Secondary Outcome Measures

change from baseline in "average pain" score on the brief pain inventory
Variation of the average pain at several time-points during the 4 weeks follow-up
Location of MRI abnormalities
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
Number of participants with adverse events as a measure of safety and tolerability
change from baseline in specific questionnaires

Full Information

First Posted
February 6, 2014
Last Updated
February 15, 2021
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02059096
Brief Title
Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
Acronym
STIMASEP
Official Title
Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2014 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis With Central Neuropathic Pain
Keywords
Multiple Sclerosis, Repetitive transcranial magnetic stimulation (rTMS), Chronic neuropathic pain, Cortical excitability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repetitive transcranial magnetic stimulation (rTMS)
Arm Type
Experimental
Arm 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
Arm Title
Theta-Burst Stimulation (pcTBS)
Arm Type
Other
Arm 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.
Arm Title
repetitive Transcranial Magnetic Stimulation (rTMS)placebo
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Primary Outcome Measure Information:
Title
Change from baseline in "average pain" score on the brief pain inventory
Description
Variation of the "Average pain" score on the Brief Pain Inventory between before treatment (on a 7 days period) and day 8.
Time Frame
at day 8
Secondary Outcome Measure Information:
Title
change from baseline in "average pain" score on the brief pain inventory
Description
Variation of the average pain at several time-points during the 4 weeks follow-up
Time Frame
at weekk 3 and 4
Title
Location of MRI abnormalities
Description
Correlation between pain and pain decrease with MRI abnormalities in several regions of interest
Time Frame
at week 3 and 4
Title
Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF
Time Frame
at week 3 and 4
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
at day 1
Title
change from baseline in specific questionnaires
Time Frame
at day 8, week 3 and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
04 73 75 4963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier MOISSET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Ambroise Paré
City
Boulogne-Billancourt
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier BOUHASSIRA
First Name & Middle Initial & Last Name & Degree
Didier BOUHASSIRA
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
04 73 75 4963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Pierre Clavelou
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pascal Lefaucheur
First Name & Middle Initial & Last Name & Degree
Jean-Pascal Lefaucheur

12. IPD Sharing Statement

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

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