Neuropathic Pain Clinical Trial
Official title:
Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) of the Motor or Prefrontal Cortex in Peripheral Neuropathic Pain: a Multicenter Randomized Placebo Controlled Trial
This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of
magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain
intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with
peripheral neuropathic pain.
The medical device of study: transcranial magnetic stimulator (TMS).
The present multicenter parallel session randomized placebo controlled study (4 French
centers) aims to evaluate the long term efficacy over 25 weeks of repeated sessions of
magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain
intensity (primary outcome) and several secondary outcome measures (e.g. quality of life,
sleep, neuropathic symptoms, return to work), in patients with peripheral neuropathic pain.
The patients will be randomized to receive one of 3 treatment arms : rTMS of the motor
cortex, rTMS of the prefrontal cortex, or placebo (sham stimulation) of the motor or
prefrontal cortex. The study will be double blind, eg the patient and the investigator will
not know the nature of treatment. the stimulation protocol will consist of an induction
phasse of 5 daily sessions then a maintenance phase of several sessions : 3 sessions a week
apart, 3 sessions a fortnight apart, and 3 sessions 3 weeks apart. The statistical analysis
will be conducted in the intent to treat population and using a modified ITT analysis
excluding all the patients with protocol violation (primary outcome). The per protocol
population will also be assessed.
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