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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03259451
Other study ID # 35RC16_3045_rTMS-CIC
Secondary ID
Status Withdrawn
Phase
First received August 21, 2017
Last updated April 11, 2018
Start date September 26, 2016
Est. completion date December 31, 2017

Study information

Verified date April 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Repetitive Transcranial Magnetic Stimulation (rTMS)


Locations

Country Name City State
France CHU de Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term Improvement of pain symptoms by at least 30% on the numerical scale Day 7
Primary Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (= 1 month) Improvement of pain symptoms by at least 30% on the numerical scale Month 1
Secondary Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (> 6 months) Persistence of at least 30% improvement in pain symptoms on a numerical scale at the end of the sixth month (M6) Month 6
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