NCT02059096

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

9.1 years

First QC Date

February 6, 2014

Last Update Submit

February 15, 2021

Conditions

Multiple Sclerosis With Central Neuropathic Pain

Keywords

Multiple SclerosisRepetitive transcranial magnetic stimulation (rTMS)Chronic neuropathic painCortical excitability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • change from baseline in "average pain" score on the brief pain inventory

    at weekk 3 and 4

  • Location of MRI abnormalities

    at week 3 and 4

  • Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF

    at week 3 and 4

  • Number of participants with adverse events as a measure of safety and tolerability

    at day 1

  • change from baseline in specific questionnaires

    at day 8, week 3 and 4

Study Arms (3)

Repetitive transcranial magnetic stimulation (rTMS)

EXPERIMENTAL

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)

OTHER

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

OTHER

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)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)DEVICE
Repetitive transcranial magnetic stimulation (rTMS)Theta-Burst Stimulation (pcTBS)repetitive Transcranial Magnetic Stimulation (rTMS)placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • relapsing-remitting Multiple Sclerosis
  • 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

You may not qualify if:

  • relapse during the previous 30 days
  • contraindication for rTMS
  • peripheral neuropathic pain
  • severe depression
  • epilepsia
  • resting motor threshold above 75%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Ambroise Paré

Boulogne-Billancourt, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Xavier MOISSET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 4963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 11, 2014

Study Start

January 5, 2014

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

FR(3)