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

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ClinicalTrials.gov Identifier: NCT02059096
Recruitment Status : Recruiting
First Posted : February 11, 2014
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Hôpital Henri Mondor (Pr Jean-Pascal LEFAUCHEUR)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis With Central Neuropathic Pain. Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Phase 3

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  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
Study Start Date : February 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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)
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)
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF [ Time Frame: at week 3 and 4 ]
  4. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: at day 1 ]
  5. change from baseline in specific questionnaires [ Time Frame: at day 8, week 3 and 4 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059096


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Hôpital Henri Mondor (Pr Jean-Pascal LEFAUCHEUR)
Investigators
Principal Investigator: Xavier MOISSET University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02059096     History of Changes
Other Study ID Numbers: CHU-0179
2013-A01422-43
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Multiple Sclerosis
Repetitive transcranial magnetic stimulation (rTMS)
Chronic neuropathic pain
Cortical excitability

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neuralgia
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs