- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01800136
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
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Lyon, France, 69000
- Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL
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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
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Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days
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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
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Here the Time Frames : Baseline; 1 week; 2 week; 3 week
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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
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actimetry measures
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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
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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
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the patient is asked to evaluate each day the quality of his sleep using a numerical scale from 0 to 10.
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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
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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
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Electrical stimulation of variable intensities applied on the hand
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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
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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
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displacement of activation locus found after voluntary movements; comparison of the plastic and analgesic effects of rTMS or tDCS
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Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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