Analgesic Stimulation Non-invasive of the Motor Cortex (DOLORIS)

July 29, 2016 updated by: University Hospital, Grenoble

Evaluation of Repetitive Magnetic Stimulation Versus Direct Current Stimulation, in Chronic Neuropathic and Drug-resistant Pain Treatment

Prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more than 58 % for patients that carry a lesion of the spinal cord. This pathological condition stays a major health problem, particularly as the efficacity of available treatments is currently limited. Only 30 to 40% of patients are relieved of more than 50% of their pain by a pharmacological approach.

In case of failure, drug treatments or in addition of these ones, stimulation of the motor cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that found its place for neuropathic drug-resistant pain management only since a decade. Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are still little understood. This stimulation can be realised in a chronic and invasive way with implanted electrodes. This process allow a lasting relief for about half of operated persons, without the possibility to identify clinical selection criterion reliable for potentially responding patients for this technique.

Recently, two electrophysiological non invasive techniques have been developed, allowing to get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).

The main goal of this study is to compare the importance of analgesic effect of tDCS in chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already validated by data of the literature.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Contact Backup

Study Locations

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons affiliated to national social security.
  • Patients that have given their signed free consent.
  • Patients from 18 to 80 years, men or women, carriers of a chronic neuropathic pain (since more than a year ; EVN > 2during week S0) drug resistant, unilateral, involving at least the superior member and/or hemi-face, whose analgesic treatment is stable from at least one month.
  • Patients whose drug resistance conduce their referent Algologist (specialist in pain medicine) to study the possibility to propose them alternative therapeutic solutions nonpharmacological and to start a pre-surgical examination.

Exclusion Criteria:

  • History of drug addiction, migraine, epilepsy.
  • Presence of ferromagnetic intracranial equipment or a stimulating implanted (pace-maker, stimulation of basal ganglia, vagus nerve stimulator).
  • Introduction of a new analgesic treatment since at least a month.
  • Pregnant, parturient or breastfeeding women. The absence of effective contraception during all the study for patients of childbearing age.
  • Persons deprived of liberty by judicial or administrative decision, person under legal protection.
  • Counter-argument to MRI.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MRI by rTMS
Patients which received an MRI study of cortical plasticity by rTMS.
Device: rTMS session
Repetitive transcranial magnetic stimulation.
Other Names:
  • MRI
ACTIVE_COMPARATOR: MRI by tDCS
Patients which received an MRI study of cortical plasticity by tDCS.
Device: tDCS session
Direct current transcranial magnetic stimulation
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-frequency
Time Frame: Half an hour

rTMS session : repetitive transcranial magnetic stimulation.

MRI
Half an hour
High-frequency
Time Frame: Half an hour

tDCS session : direct current transcranial magnetic stimulation.

MRI
Half an hour

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Hasan Hodaj, Doctor, Grenoble Hospital University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.130

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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