Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,

NCT04936646 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Grenoble

Phase

Not applicable

Started

2021-07-16

Last updated

2024-12-06

Condition(s) studied

Chronic Neuropathic Pain

Investigational drug(s) / intervention(s)

RepetitiveTranscranial Magnetic Stimulation (rTMS)

RepetitiveTranscranial Magnetic Stimulation (rTMS): The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Evolution of Pain. — Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better).

Trial sites (1)

Facility	City	Region	Status
Centre de la douleur, CHU Grenoble Alpes	Grenoble	Isère	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04936646 on ClinicalTrials.gov ↗ ← All trials in France