Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

NCT ID: NCT02386969

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-11

Study Completion Date

2018-09-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active rTMS then sham rTMS

Active rTMS in 1st period and sham rTMS in 2nd period

Group Type EXPERIMENTAL

active rTMS then sham rTMS

Intervention Type DEVICE

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

Sham rTMS then active rTMS

Sham rTMS in 1st period and active rTMS in 2nd period

Group Type EXPERIMENTAL

sham rTMS then active rTMS

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland PEYRON, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00065-44

Identifier Type: OTHER

Identifier Source: secondary_id

1408207

Identifier Type: -

Identifier Source: org_study_id

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