Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy

NCT ID: NCT01800136

Last Updated: 2019-09-03

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-13

Study Completion Date

2019-06-17

Brief Summary

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The aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different from placebo; this effect is clinically useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its efficacy in neuropathic pain has been not yet established. The investigators propose to compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed before and after the five sessions of rTMS and tDCS, in order to reveal the potential plasticity induced within motor somatotopic map of the primary motor cortex.

Detailed Description

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Conditions

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Pharmacoresistant Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rTMS; tDCS

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation

Intervention Type DEVICE

Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days

Interventions

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Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation

Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients aged from 18 to 80 years, male or female, fully informed and having given their written consent
* pharmacoresistant neuropathic pain during at least one year, without any change of the pharmacological treatment since at least one month

Exclusion Criteria

* drug addiction, headache, epilepsy history
* ferromagnetic intracranial device
* implanted stimulator
* absence of contraceptive method for women of childbearing age
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2008-A01379-32

Identifier Type: OTHER

Identifier Source: secondary_id

2011.662

Identifier Type: -

Identifier Source: org_study_id

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