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

Multiple Sclerosis With Central Neuropathic Pain Clinical Trial

— STIMASEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059096
• Other study ID #: CHU-0179
• Secondary ID: 2013-A01422-43
• Status: Recruiting
• Phase: Phase 3
• Start date: January 5, 2014
• Est. completion date: February 2023

Study information

• Verified date: February 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 4963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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%

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis With Central Neuropathic Pain
• Neuralgia
• Sclerosis

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)

Locations

Country	Name	City	State
France	CHU Ambroise Paré	Boulogne-Billancourt
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at day 8
Secondary	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	at weekk 3 and 4
Secondary	Location of MRI abnormalities	Correlation between pain and pain decrease with MRI abnormalities in several regions of interest	at week 3 and 4
Secondary	Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF		at week 3 and 4
Secondary	Number of participants with adverse events as a measure of safety and tolerability		at day 1
Secondary	change from baseline in specific questionnaires		at day 8, week 3 and 4