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

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ClinicalTrials.gov Identifier: NCT03259451
Recruitment Status : Withdrawn (No recruitment)
First Posted : August 23, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment
Chronic Neuropathic Pain Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : September 26, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with chronic neuropathic pain
Criteria

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

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): NCT03259451


Locations
France
CHU de Rennes
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03259451     History of Changes
Other Study ID Numbers: 35RC16_3045_rTMS-CIC
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms