rTMS Efficacy Coupled With Mirror Therapy

NCT ID: NCT04867187

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type OTHER

20 minutes of high frequency (20Hz) rTMS.

Mirror therapy using virtual reality

Intervention Type OTHER

active mirror-based therapy

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.

Group Type SHAM_COMPARATOR

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type OTHER

20 minutes of high frequency (20Hz) rTMS.

Mirror therapy using sham mirror

Intervention Type OTHER

20 minutes of sham mirror-based therapy

Interventions

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Repetitive transcranial magnetic stimulation (rTMS)

20 minutes of high frequency (20Hz) rTMS.

Intervention Type OTHER

Mirror therapy using virtual reality

active mirror-based therapy

Intervention Type OTHER

Mirror therapy using sham mirror

20 minutes of sham mirror-based therapy

Intervention Type OTHER

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Peyron, MDPHD

Role: PRINCIPAL_INVESTIGATOR

CENTRE HOSPITALIER DE SAINT-ETIENNE

Locations

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Hôpital Neurologique Pierre Wertheimer

Bron, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Roland Peyron, MDPHD

Role: CONTACT

(0)477825684 ext. +33

Beatrice DEYGAS, CRA

Role: CONTACT

Facility Contacts

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Luis Garcia-Larrea, MD

Role: primary

0)472118866 ext. +33

Roland PEYRON, MD PHD

Role: primary

(0)477825684 ext. +33

Other Identifiers

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2021-A00720-41

Identifier Type: OTHER

Identifier Source: secondary_id

21CH035

Identifier Type: -

Identifier Source: org_study_id

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