rTMS Efficacy Coupled With Mirror Therapy

NCT04867187 | Recruiting

• 2 other identifiers: 21CH0352021-A00720-41
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuropathic Pain

Keywords

transcranial magnetic stimulation; virtual reality; mirror therapy; brain networks; predictive model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of life after treatment

  week 12

• Spontaneous brain activity

  week 12

• neuropathic dimension

  Week 3, 5, 7, 9,12

• Adverse events

  Week 3, 5, 7, 9,12

Study Arms (2)

rTMS active and active mirror-based therapy using virtual reality

EXPERIMENTAL

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); Other: Mirror therapy using virtual reality

rTMS active and sham mirror-based therapy using virtual reality

SHAM COMPARATOR

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); Other: Mirror therapy using sham mirror

Interventions

Repetitive transcranial magnetic stimulation (rTMS) OTHER

20 minutes of high frequency (20Hz) rTMS.

rTMS active and active mirror-based therapy using virtual reality; rTMS active and sham mirror-based therapy using virtual reality

Mirror therapy using virtual reality OTHER

active mirror-based therapy

rTMS active and active mirror-based therapy using virtual reality

Mirror therapy using sham mirror OTHER

20 minutes of sham mirror-based therapy

rTMS active and sham mirror-based therapy using virtual reality

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

Hôpital Neurologique Pierre Wertheimer

Bron, 69500, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Roland Peyron, MDPHD

  CENTRE HOSPITALIER DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Peyron, MDPHD

CONTACT

(0)477825684; roland.peyron@univ-st-etienne.fr

Beatrice DEYGAS, CRA

CONTACT

beatrice.deygas@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The (motor) task performed by the patient during the sham control mirror therapy session is identical to that performed in active mirror therapy. The only difference is that in sham mirror therapy there is no optical illusion of movement of the affected hand.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: patient with 4 sessions of active mirror therapy followed by an rTMS stimulation session of the primary motor cortex (M1), Group 2: patient with 4 sessions of sham mirror therapy followed by rTMS of the primary motor cortex (M1).

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: October 27, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)