Study of rTMS Analgesic Effect in Chronic Neuropathic Pain

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    45
  • sponsor
    University Hospital, Grenoble
Updated on 15 September 2021

Summary

The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:

  • Classical rTMS stimulation
  • Deeper rTMS stimulation
  • Sham rTMS stimulation

Description

Conduct of study:

  • Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient.
  • Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.
  • Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks.
  • After the end of neurostimulation sessions, patients will be followed for 2 weeks.
  • Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Details
Condition Chronic Neuropathic Pain
Treatment RepetitiveTranscranial Magnetic Stimulation (rTMS)
Clinical Study IdentifierNCT04936646
SponsorUniversity Hospital, Grenoble
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient's written consent
Affiliated with social security system
Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain
Patient whose analgesic treatment, is stable for at least 1 month
Patient not responding to conventional treatments
Prescreening EVN >3

Exclusion Criteria

History of drug addiction, epilepsy, cranial trauma
History of psychiatric disorder
Patients previously treated with rTMS
Patient with intracranial ferromagnetic material or implanted stimulator
New treatment for less than one month
Pregnant or Breastfeeding woman
Patient who does not understand the study protocol
Persons who are protected under the act
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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