Study Results
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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RECRUITING
NA
64 participants
INTERVENTIONAL
2022-10-27
2027-04-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Repetitive transcranial magnetic stimulation (rTMS)
20 minutes of high frequency (20Hz) rTMS.
Mirror therapy using virtual reality
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.
Repetitive transcranial magnetic stimulation (rTMS)
20 minutes of high frequency (20Hz) rTMS.
Mirror therapy using sham mirror
20 minutes of sham mirror-based therapy
Interventions
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Repetitive transcranial magnetic stimulation (rTMS)
20 minutes of high frequency (20Hz) rTMS.
Mirror therapy using virtual reality
active mirror-based therapy
Mirror therapy using sham mirror
20 minutes of sham mirror-based therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
18 Years
85 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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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
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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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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