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DOLORIS: Analgesic Stimulation Non-invasive of the Motor Cortex

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Unknown status
CT.gov ID
NCT02854332
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
42
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: tDCS session
  • Device: rTMS session
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Repetitive Magnetic Stimulation Versus Direct Current Stimulation, in Chronic Neuropathic and Drug-resistant Pain Treatment
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. High-frequency [Half an hour]

      rTMS session : repetitive transcranial magnetic stimulation. MRI

    2. High-frequency [Half an hour]

      tDCS session : direct current transcranial magnetic stimulation. MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UniversityHospitalGrenoble La Tronche France 38700

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT02854332
    Other Study ID Numbers:
    • 38RC14.130
    First Posted:
    Aug 3, 2016
    Last Update Posted:
    Aug 3, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by University Hospital, Grenoble
    Pain
    Analgesic
    Stimulation
    Motor Cortex
    Additional relevant MeSH terms:
    Chronic Pain

    Study Results

    No Results Posted as of Aug 3, 2016