sponsor decision

The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation at the subacute phase of stroke (between day 7 and day 14) improves significantly arm motility at 3 months with remaining effect at one year, without significant adverse effect.

Stroke survivors may be left with disability involving speech or residual arm or leg weakness. Despite spontaneous improvement on the weeks following stroke, the importance of final disability is unpredictable. If the core of the infarct is represented by dead neurons, the neurons from adjacent areas seem to be staggered and their lack of excitability has been correlated to a bad prognosis. Repetitive transcranial magnetic stimulation (rTMS) seems to be a promising technique since high frequency rTMS can increase excitability of the targeted neurons.

The aim of the study is to evaluate after 2 weeks of 20 min of rTMS each day: 1) the improvement of arm function and neurological and disability scales, immediately after the 2-week session, at one month, 3 months and evaluate the remnant effect at 12 months, 2) to correlate these scales to physiological parameters in order to assess the clinical modifications to the electrophysiological modifications, 3) to assert the safety of high frequency rTMS at the subacute phase of ischaemic stroke.

Inclusion Criteria:

Single mono hemispheric subcortical and/or cortical ischaemic stroke (documented by CT or MRI) 7 to 21 days before, with moderate arm paresis as defined by a Rankin score <= 4 or not at 4 (in paragraph 5 of NIHSS), in the territory of middle cerebral artery Patients between 18 and 80 years old

Exclusion Criteria:

severe peripheral neuropathy pace-maker, implanted medical pump, metal plate, metal object in the skull or eye History of previous stroke, epileptic seizures, craniotomy, brain trauma Score Rankin > 4 and arm deficit at 4 (paragraph 5 of NIHSS) Score Rankin <=1 Cortical stroke Alertness problems at the time of inclusion Disability previous to stroke Stenosis of internal carotid artery with surgery foreseen within 3 months Uncontrolled medical problem Not able to give informed consent Pregnant or breast-feeding woman