rTMS Efficacy Coupled With Mirror Therapy (STIRM)

Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy 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 present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain
• Intervention / Treatment: Other: Repetitive transcranial magnetic stimulation (rTMS); Other: Mirror therapy using virtual reality; Other: Mirror therapy using sham mirror

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roland Peyron, MDPHD; Phone Number: +33 (0)477825684; Email: roland.peyron@univ-st-etienne.fr
• Study Contact Backup: Name: Beatrice DEYGAS, CRA; Email: beatrice.deygas@chu-st-etienne.fr

Study Locations

• France
  • Bron, France, 69500
    • Not yet recruiting
    • Hôpital Neurologique Pierre Wertheimer
    • Contact: Luis Garcia-Larrea, MD; Phone Number: +33 0)472118866; Email: luis-jose.garcia-larrea@chu-lyon.fr
    • Principal Investigator: Patrick MERTENS, MD PhD
    • Sub-Investigator: Nathalie ANDRE-OBADIA, MD
    • Sub-Investigator: Luis GARCIA- LARREA, MD
  • Saint-Etienne, France, 42055
    • Recruiting
    • Centre Hospitalier Universitaire de Saint-Etienne
    • Contact: Roland PEYRON, MD PHD; Phone Number: +33 (0)477825684; Email: roland.peyron@chu-st-etienne.fr
    • Sub-Investigator: Christelle Créac'h, MD
    • Principal Investigator: Roland PEYRON, MD PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS active and active mirror-based therapy using virtual reality; The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and active mirror-based therapy using virtual reality.	Other: Repetitive transcranial magnetic stimulation (rTMS); 20 minutes of high frequency (20Hz) rTMS.; Other: Mirror therapy using virtual reality; active mirror-based therapy
Sham Comparator: rTMS active and sham mirror-based therapy using virtual reality; The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and sham mirror-based therapy using virtual reality.	Other: Repetitive transcranial magnetic stimulation (rTMS); 20 minutes of high frequency (20Hz) rTMS.; Other: Mirror therapy using sham mirror; 20 minutes of sham mirror-based therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measurement	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)	Week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life after treatment	EQ5D scale (min = 0 worst imaginable health condition and max = 100 best health condition imaginable) and Analgesic consumption of Appeal	week 12
Spontaneous brain activity	Functional MRI at rest	week 12
neuropathic dimension	overall score of the neuropathic pain symptoms inventory (NPSI) (min = 0 no neuropathic pain and max = 100 intensive neuropathic pain)	Week 3, 5, 7, 9,12
Adverse events	Nature and number of adverse events	Week 3, 5, 7, 9,12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Roland Peyron, MDPHD, CENTRE HOSPITALIER DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: virtual reality; predictive model; transcranial magnetic stimulation; mirror therapy; brain networks
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 21CH035; 2021-A00720-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No