Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02854332
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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
Neuropathic Chronic Pain Device: tDCS session Device: rTMS session Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 Name: 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 Name: MRI




Primary Outcome Measures :
  1. High-frequency [ Time Frame: Half an hour ]

    rTMS session : repetitive transcranial magnetic stimulation.

    MRI


  2. High-frequency [ Time Frame: Half an hour ]

    tDCS session : direct current transcranial magnetic stimulation.

    MRI




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854332


Contacts
Layout table for location contacts
Contact: Hasan Hodaj, Doctor 0476765213 HHodaj@chu-grenoble.fr
Contact: Jean-Pierre Alibeu, Doctor 04 76 76 52 13 JPAlibeu@chu-grenoble.fr

Locations
Layout table for location information
France
UniversityHospitalGrenoble Recruiting
La Tronche, France, 38700
Contact: Hasan Hodaj, Doctor    0476765213    HHodaj@chu-grenoble.fr   
Contact: Jean-Pierre Alibeu, Doctor    04 76 76 52 13    JPAlibeu@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Hasan Hodaj, Doctor Grenoble Hospital University
Publications:
H. Hodaj, C. Maindet Dominici ,JP. Alibeu. Intérêt de la neuronavigation dans la pratique de la stimulation magnétique transcrânienne repetitive (SMTr) Douleurs, 2011, Vol.12 A77
Hodaj H, Alibeu JP, Dominici C, D, Szekely D, Jacquot C. Traitement des douleurs réfractaires de la face par la stimulation magnétique transcranienne répétitive (SMTr) : étude ouverte sur une année Douleurs ; 2010, Vol. 11, 280-287
Hodaj H, Pellat J, Szekely D, Alibeu JP, Bougerol T, Jacquot C. Utilisation de la stimulation magnétique transcranienne répétitive(SMTr) dans le traitement de la douleur neuropathique chronique résistante aux thérapeutiques conventionnelles. Douleurs, 2007,8, 1S62

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02854332    
Other Study ID Numbers: 38RC14.130
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Grenoble:
Pain
Analgesic
Stimulation
Motor Cortex
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations