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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01059149
First received: January 28, 2010
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Nervous System Diseases
Stroke
Cerebrovascular Disorders
Brain Infarction
Brain Ischemia
Device: repetitive transcranial magnetic stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improvement of neurological score (NIHSS), disability scales (Barthel, Rankin), spasticity scales (Ashworth) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Period before the patient is able to go back home [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Influence of the side of the stimulation on depression (Hamilton scale) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: November 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059149

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01059149     History of Changes
Other Study ID Numbers: P080604
Study First Received: January 28, 2010
Last Updated: November 21, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rehabilitation
Transcranial magnetic stimulation
Brain magnetic stimulation
Repetitive
Stroke
Subacute

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

ClinicalTrials.gov processed this record on October 19, 2014