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

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ClinicalTrials.gov Identifier: NCT01059149
Recruitment Status : Terminated (sponsor decision)
First Posted : January 29, 2010
Last Update Posted : January 16, 2015
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 Type : Interventional  (Clinical Trial)
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 : November 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

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)

Primary Outcome Measures :
  1. 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 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 year ]
  2. Improvement of neurological score (NIHSS), disability scales (Barthel, Rankin), spasticity scales (Ashworth) [ Time Frame: 1 year ]
  3. 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) [ Time Frame: 1 year ]
  4. Period before the patient is able to go back home [ Time Frame: 1 year ]
  5. Influence of the side of the stimulation on depression (Hamilton scale) [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059149

Physiology Department, Hôpital Lariboisière, Université Paris 7
Paris, Ile de France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: KUBIS Nathalie, MD, PhD Physiology Department, Hôpital Lariboisière, Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01059149     History of Changes
Other Study ID Numbers: P080604
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: November 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Transcranial magnetic stimulation
Brain magnetic stimulation

Additional relevant MeSH terms:
Nervous System Diseases
Cerebrovascular Disorders
Brain Ischemia
Brain Infarction
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes