CClinicalTrials.gg
WithdrawnNCT03259451rTMS-CICUpdated Apr 12, 2018

Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain

An observational study in Chronic Neuropathic Pain, sponsored by Rennes University Hospital. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by Rennes University Hospital · Observational

Why this study was withdrawn
No recruitment
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Neuropathic Pain

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with chronic neuropathic pain

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

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation (rTMS)
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 7

  2. 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

    Time frame: Month 1

Secondary outcomes

  1. 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)

    Time frame: Month 6

06

Study locations

1 site
  • CHU de Rennes
    Rennes, 35033, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03259451
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Sep 26, 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Apr 12, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion