rTMS Efficacy Coupled With Mirror Therapy

Official title

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

Overview

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.

Interventions

• Other Repetitive transcranial magnetic stimulation (rTMS)
  20 minutes of high frequency (20Hz) rTMS.
• Other Mirror therapy using virtual reality
  active mirror-based therapy
• Other Mirror therapy using sham mirror
  20 minutes of sham mirror-based therapy

Primary outcome measures

• Pain intensity measurement [Time frame: Week 9]

Secondary outcome measures (4)

• Quality of life after treatment [Time frame: week 12]
• Spontaneous brain activity [Time frame: week 12]
• neuropathic dimension [Time frame: Week 3, 5, 7, 9,12]
• Adverse events [Time frame: Week 3, 5, 7, 9,12]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

France · 2 centers

• Hôpital Neurologique Pierre Wertheimer — Bron
• Centre Hospitalier Universitaire de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT04867187 · 21CH035 · 2021-A00720-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗