Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

April 23, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne

Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Saint-etienne, France, 42055
        • CHU Saint-Etienne

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Central neuropathic pain
  • Chronic pain with an average pain intensity is greater than or equal to 40/100
  • Pain presents a daily or almost daily (at least 4 days out of 7)
  • Pain presents for more than 6 months
  • Patients who signed informed consent,
  • Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
  • Patients can be monitored for the duration of the study (29 weeks)
  • Patients affiliated to a health insurance plan or entitled,
  • Patients with a cerebral MRI T1.

Exclusion Criteria:

  • Labor dispute or Accident,
  • Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
  • Abuse of drugs or psychoactive substances
  • Peripheral Neuropathic Pain,
  • Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
  • Intermittent pain,
  • Pain in less than 6 months,
  • Presence of other pain more severe than that justify inclusion,
  • Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
  • Patients unable to understand informed consent, under guardianship,
  • Patients refusing to stop or can not stop the prohibited treatment during the study,
  • Patients participating in another research protocol involving a drug within 30 days before inclusion.

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active rTMS then sham rTMS
Active rTMS in 1st period and sham rTMS in 2nd period
Device: active rTMS then sham rTMS
A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months
EXPERIMENTAL: Sham rTMS then active rTMS
Sham rTMS in 1st period and active rTMS in 2nd period
Device: sham rTMS then active rTMS
A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")
Time Frame: 3 weeks later the last session of rTMS (active ) so week n°12
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
3 weeks later the last session of rTMS (active ) so week n°12
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain
Time Frame: 3 weeks later the last session of rTMS (sham) so week n°29.
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
3 weeks later the last session of rTMS (sham) so week n°29.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").
Time Frame: 3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.
3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.
Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Time Frame: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Time Frame: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Neuropathic dimension
Time Frame: at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)
specific paper questionnaire of neuropathic pain NPSI at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)
at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)
- Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.
Time Frame: at the end of each period of 4 sessions (weeks n°12 and 29)
at the end of each period of 4 sessions (weeks n°12 and 29)
Consumption of analgesic treatment
Time Frame: 3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29
3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Roland PEYRON, MD PhD, Chu de Saint-Etienne

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)

November 11, 2015

Primary Completion (ACTUAL)

March 29, 2018

Study Completion (ACTUAL)

September 12, 2018

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (ESTIMATE)

March 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408207
  • 2015-A00065-44 (OTHER: ANSM)

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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