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NCT Number: NCT04867187

rTMS Efficacy Coupled With Mirror Therapy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Neurologique Pierre Wertheimer, Bron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Other

20 minutes of high frequency (20Hz) rTMS.

Mirror therapy using virtual reality

Other

active mirror-based therapy

Mirror therapy using sham mirror

Other

20 minutes of sham mirror-based therapy

Primary outcomes

  1. Pain intensity measurement

    Time frame: 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 outcomes

  1. Quality of life after treatment

    Time frame: week 12

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

  2. Spontaneous brain activity

    Time frame: week 12

    Functional MRI at rest

  3. neuropathic dimension

    Time frame: 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)

  4. Adverse events

    Time frame: Week 3, 5, 7, 9,12

    Nature and number of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice DEYGAS, CRA

CONTACT

[email protected]

Roland Peyron, MDPHD

CONTACT

[email protected]

(0)477825684 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief

Acronym: STIRM

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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