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Clinical Trials/NCT04867187
NCT04867187
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne2 sites in 1 country64 target enrollmentOctober 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuropathic Pain
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
64
Locations
2
Primary Endpoint
Pain intensity measurement
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 27, 2022
End Date
April 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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.).

Outcomes

Primary Outcomes

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

  • Spontaneous brain activity(week 12)
  • Adverse events(Week 3, 5, 7, 9,12)
  • Quality of life after treatment(week 12)
  • neuropathic dimension(Week 3, 5, 7, 9,12)

Study Sites (2)

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