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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Study Start: 2022-10-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-12
• Study Completion: 2027-04

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

Name	Time	Method
Pain intensity measurement	Week 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

Name	Time	Method
Spontaneous brain activity	week 12	Functional MRI at rest
Adverse events	Week 3, 5, 7, 9,12	Nature and number of adverse events
Quality of life after treatment	week 12	EQ5D scale (min = 0 worst imaginable health condition and max = 100 best health condition imaginable) and Analgesic consumption of Appeal
neuropathic dimension	Week 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