Trials / Completed
CompletedNCT02386969
Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain
Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.
Detailed description
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | active rTMS then sham rTMS | A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months |
| DEVICE | sham rTMS then active rTMS | A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months |
Timeline
- Start date
- 2015-11-11
- Primary completion
- 2018-03-29
- Completion
- 2018-09-12
- First posted
- 2015-03-12
- Last updated
- 2021-04-26
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02386969. Inclusion in this directory is not an endorsement.