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

Primary Purpose

Pharmacoresistant Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharmacoresistant Neuropathic Pain focused on measuring pain, neuropathic, cortical stimulation, motor cortex, plasticity, rTMS, tDCS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rTMS; tDCS

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

objective evaluation of sleep quality
actimetry measures
subjective evaluation of sleep quality using a numerical auto-evaluation scale
the patient is asked to evaluate each day the quality of his sleep using a numerical scale from 0 to 10.
nociceptive and non-nociceptive thresholds
Electrical stimulation of variable intensities applied on the hand
evaluation of motor cortex plasticity
displacement of activation locus found after voluntary movements; comparison of the plastic and analgesic effects of rTMS or tDCS

Full Information

First Posted
October 30, 2012
Last Updated
August 30, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01800136
Brief Title
Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy
Acronym
NI-MCS
Official Title
Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 13, 2013 (Actual)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharmacoresistant Neuropathic Pain
Keywords
pain, neuropathic, cortical stimulation, motor cortex, plasticity, rTMS, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS; tDCS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
Intervention Description
Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
objective evaluation of sleep quality
Description
actimetry measures
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
Title
subjective evaluation of sleep quality using a numerical auto-evaluation scale
Description
the patient is asked to evaluate each day the quality of his sleep using a numerical scale from 0 to 10.
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
Title
nociceptive and non-nociceptive thresholds
Description
Electrical stimulation of variable intensities applied on the hand
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
Title
evaluation of motor cortex plasticity
Description
displacement of activation locus found after voluntary movements; comparison of the plastic and analgesic effects of rTMS or tDCS
Time Frame
Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL
City
Lyon
ZIP/Postal Code
69000
Country
France

12. IPD Sharing Statement

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

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