Clinical trial NCT01059149: Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation of Stroke (RAICup)
Official title: Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation at the Subacute Phase of Ischaemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nervous System Diseases
Stroke
Cerebrovascular Disorders
Brain Infarction
Brain Ischemia
Keywords: Rehabilitation
Transcranial magnetic stimulation
Brain magnetic stimulation
Repetitive
Stroke
Subacute
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in the arm function in patients treated with rTMS as measured by the ARA (Action Research Arm) test at 3 months follow-up compared to the sham treated patients
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of hand function as measured by ARA test and Box and Block test at 2-week, 1 month, 3 months and 1 year follow-up
timeFrame: 1 year
measure: Improvement of neurological score (NIHSS), disability scales (Barthel, Rankin), spasticity scales (Ashworth)
timeFrame: 1 year
measure: Identify groups of good and bad responders in correlation to other excitability parameters and other parameters known to impede functional outcome (importance of the initial deficit, infarct volume, lesion on the CORTICO-spinal tract)
timeFrame: 1 year
measure: Period before the patient is able to go back home
timeFrame: 1 year
measure: Influence of the side of the stimulation on depression (Hamilton scale)
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Physiology Department, Hôpital Lariboisière, Université Paris 7
state: Ile de France
Study officials:
affiliation: Physiology Department, Hôpital Lariboisière, Paris
name: KUBIS Nathalie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: