Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain (rTMS-CIC)

April 11, 2018 updated by: Rennes University Hospital

Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain: Retrospective Study on a Cohort of 149 Patients at Rennes University Hospital, From January 2014 to December 2015

A retrospective, monocentric, observational, descriptive, open study of a cohort of 149 patients from January 2014 to December 2015

Study Overview

Detailed Description

Neuropathic pain is a public health problem because of its prevalence reaching nearly 7% of the general population and the effectiveness of current treatments often remains incomplete: only 30-40% of patients are relieved of 50% of their pain by a pharmacological approach.

As early as the 1990s, stimulation of the motor cortex by implanted electrodes made it possible to successfully treat certain chronic refractory neuropathic pain. In 1995 it was reported that the application of repeated shocks by transcranial magnetic stimulation of the motor cortex could induce an analgesic effect in a patient suffering from neuropathic pain.

This technique has proved its analgesic efficacy after an induction treatment over 5 days, in the context of chronic pain (neuropathic or fibromyalgia), but all the patients are not responders and there is currently, Of predictive criteria for response. It seems important to continue studies on this non-medicinal, non-invasive therapy with no significant adverse effects.

Study Type

Observational

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

      • Rennes, France, 35033
        • CHU de Rennes

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with chronic neuropathic pain

Description

Inclusion Criteria:

- patient older than 18 years old with chronic neuropathic pain who are resistant to drug therapy for which treatment with rTMS is indicated between January 2014 and December 2015

Exclusion Criteria:

  • Patient less than 18 years old
  • Pregnant woman
  • Non-neuropathic pain
  • Pain <6 months
  • Unbalanced epilepsy
  • Patient with a contraindication for cerebral MRI (cochlear implant, ocular metallic foreign bodies, patient with a pacemaker, mechanical valve)
  • Psychiatric pathology
  • Person subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term
Time Frame: Day 7
Improvement of pain symptoms by at least 30% on the numerical scale
Day 7
Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (≤ 1 month)
Time Frame: Month 1
Improvement of pain symptoms by at least 30% on the numerical scale
Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (> 6 months)
Time Frame: Month 6
Persistence of at least 30% improvement in pain symptoms on a numerical scale at the end of the sixth month (M6)
Month 6

Collaborators and Investigators

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

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)

September 26, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC16_3045_rTMS-CIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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