Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation of Stroke (RAICup)

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Terminated

CT.gov ID

NCT01059149

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nervous System Diseases Stroke Cerebrovascular Disorders Brain Infarction Brain Ischemia	Device: repetitive transcranial magnetic stimulation	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation at the Subacute Phase of Ischaemic Stroke

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: receive real rTMS For real rTMS, pulses will be delivered at a frequency of 5 Hz for 6s with a 54s interval, with an intensity equal of 90% of the motor threshold as established at Baseline. 20-min real stimulation sessions will be administered 5 days a week for a period of 2 weeks	Device: repetitive transcranial magnetic stimulation MagPro x100 (MagVenture A/S, DANEMARK)
Placebo Comparator: sham rTMS For sham rTMS, procedures will be identical to those used for real rTMS with the exception that a placebo procedures will be used administered 5 days a week for a period of 2 weeks.	Device: repetitive transcranial magnetic stimulation MagPro x100 (MagVenture A/S, DANEMARK)

Arm

Intervention/Treatment

Experimental: receive real rTMS

For real rTMS, pulses will be delivered at a frequency of 5 Hz for 6s with a 54s interval, with an intensity equal of 90% of the motor threshold as established at Baseline. 20-min real stimulation sessions will be administered 5 days a week for a period of 2 weeks

Device: repetitive transcranial magnetic stimulation

MagPro x100 (MagVenture A/S, DANEMARK)

Placebo Comparator: sham rTMS

For sham rTMS, procedures will be identical to those used for real rTMS with the exception that a placebo procedures will be used administered 5 days a week for a period of 2 weeks.

Device: repetitive transcranial magnetic stimulation

MagPro x100 (MagVenture A/S, DANEMARK)

Outcome Measures

Primary Outcome Measures

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 [3 months]

Secondary Outcome Measures

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 [1 year]
Improvement of neurological score (NIHSS), disability scales (Barthel, Rankin), spasticity scales (Ashworth) [1 year]
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) [1 year]
Period before the patient is able to go back home [1 year]
Influence of the side of the stimulation on depression (Hamilton scale) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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