MedPath

rTMS Efficacy Coupled With Mirror Therapy

Not Applicable
Recruiting
Conditions
Neuropathic Pain
Registration Number
NCT04867187
Lead Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Brief Summary

Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

Detailed Description

This project introduces a new research question that incorporates virtual reality mirror therapy into an established treatment protocol of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain relief. Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.

Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS. The efficacy of using both techniques in neuropathic pain treatment is unknown. The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy on: 1) daily pain intensity (i.e. analgesic efficacy); 2) other components of pain and the quality of life; 3) brain activity.

It will be the first to provide insight into the efficacy of using together both non-invasive technics of cortical neuromodulation to alleviate pain.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
64
Inclusion Criteria
  • Clinical symptoms typical of neuropathic pain
  • Refractory to drug therapies
  • Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least
  • Having right to health benefits
Exclusion Criteria
  • Ferromagnetic components and implanted microprocessors (i.e. cochlear implants)
  • Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment.
  • Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Pain intensity measurementWeek 9

Averages of the daily visual analogue scale scores (min no pain max pain imaginable) measured during the first week (Week 1) and that measured during the week following the last session (week 9)

Secondary Outcome Measures
NameTimeMethod
Spontaneous brain activityweek 12

Functional MRI at rest

Adverse eventsWeek 3, 5, 7, 9,12

Nature and number of adverse events

Quality of life after treatmentweek 12

EQ5D scale (min = 0 worst imaginable health condition and max = 100 best health condition imaginable) and Analgesic consumption of Appeal

neuropathic dimensionWeek 3, 5, 7, 9,12

overall score of the neuropathic pain symptoms inventory (NPSI) (min = 0 no neuropathic pain and max = 100 intensive neuropathic pain)

Trial Locations

Locations (2)

Hôpital Neurologique Pierre Wertheimer

🇫🇷

Bron, France

Centre Hospitalier Universitaire de Saint-Etienne

🇫🇷

Saint-Étienne, France

Hôpital Neurologique Pierre Wertheimer
🇫🇷Bron, France
Luis Garcia-Larrea, MD
Contact
0)472118866
luis-jose.garcia-larrea@chu-lyon.fr
Patrick MERTENS, MD PhD
Principal Investigator
Nathalie ANDRE-OBADIA, MD
Sub Investigator
Luis GARCIA- LARREA, MD
Sub Investigator

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.