Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy (NI-MCS)

August 30, 2019 updated by: Hospices Civils de Lyon

Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • France
      • Lyon, France, 69000
        • Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL

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:

  • 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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS; tDCS
Device: Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Pain at the end of the stimulation week Change from Baseline in Pain at the end of the first post-stimulation week Change from Baseline in Pain at the end of the second post-stimulation week
Time Frame: Here the Time Frames : Baseline; 1 week; 2 week; 3 week
Here the Time Frames : Baseline; 1 week; 2 week; 3 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective evaluation of sleep quality
Time Frame: Change from Baseline in percentage of sleep time at the end of the stimulation week; at the end of the first post-stimulation week; and at the end of the of the second post-stimulation week
actimetry measures
Change from Baseline in percentage of sleep time at the end of the stimulation week; at the end of the first post-stimulation week; and at the end of the of the second post-stimulation week
subjective evaluation of sleep quality using a numerical auto-evaluation scale
Time Frame: Change from Baseline in level of tiredness at the end of the stimulation week;at the end of the first post-stimulation week; and at the end of the second post-stimulation week
the patient is asked to evaluate each day the quality of his sleep using a numerical scale from 0 to 10.
Change from Baseline in level of tiredness at the end of the stimulation week;at the end of the first post-stimulation week; and at the end of the second post-stimulation week
nociceptive and non-nociceptive thresholds
Time Frame: Change from Baseline in nociceptive threshold after the first day of stimulation;after the fifth day of stimulation;Change from Baseline in non-nociceptive threshold after the first day of stimulation;and after the fifth day of stimulation
Electrical stimulation of variable intensities applied on the hand
Change from Baseline in nociceptive threshold after the first day of stimulation;after the fifth day of stimulation;Change from Baseline in non-nociceptive threshold after the first day of stimulation;and after the fifth day of stimulation
evaluation of motor cortex plasticity
Time Frame: Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week
displacement of activation locus found after voluntary movements; comparison of the plastic and analgesic effects of rTMS or tDCS
Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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 (Actual)

January 13, 2013

Primary Completion (Actual)

June 17, 2019

Study Completion (Actual)

June 17, 2019

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.662
  • 2008-A01379-32 (Other Identifier: ID-RCB)

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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