Clinical trial NCT04867187: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathic Pain
Keywords: transcranial magnetic stimulation
virtual reality
mirror therapy
brain networks
predictive model
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Pain intensity measurement
timeFrame: Week 9
Secondary outcomes:
measure: Quality of life after treatment
timeFrame: week 12
measure: Spontaneous brain activity
timeFrame: week 12
measure: neuropathic dimension
timeFrame: Week 3, 5, 7, 9,12
measure: Adverse events
timeFrame: Week 3, 5, 7, 9,12
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
Study officials:
affiliation: CENTRE HOSPITALIER DE SAINT-ETIENNE
name: Roland Peyron, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: