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

Primary Purpose

Nervous System Diseases, Stroke, Cerebrovascular Disorders

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

repetitive transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Nervous System Diseases focused on measuring Rehabilitation, Transcranial magnetic stimulation, Brain magnetic stimulation, Repetitive, Stroke, Subacute

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Physiology Department, Hôpital Lariboisière, Université Paris 7

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

receive real rTMS

sham rTMS

Arm Description

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

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.

Outcomes

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

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

Improvement of neurological score (NIHSS), disability scales (Barthel, Rankin), spasticity scales (Ashworth)

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)

Period before the patient is able to go back home

Influence of the side of the stimulation on depression (Hamilton scale)

Full Information

NCT ID

NCT01059149

First Posted

January 28, 2010

Last Updated

January 15, 2015

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01059149

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

sponsor decision

Study Start Date

November 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nervous System Diseases, Stroke, Cerebrovascular Disorders, Brain Infarction, Brain Ischemia

Keywords

Rehabilitation, Transcranial magnetic stimulation, Brain magnetic stimulation, Repetitive, Stroke, Subacute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

receive real rTMS

Arm Type

Experimental

Arm Description

Arm Title

sham rTMS

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

repetitive transcranial magnetic stimulation

Intervention Description

MagPro x100 (MagVenture A/S, DANEMARK)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

Improvement of neurological score (NIHSS), disability scales (Barthel, Rankin), spasticity scales (Ashworth)

Time Frame

1 year

Title

Time Frame

1 year

Title

Period before the patient is able to go back home

Time Frame

1 year

Title

Influence of the side of the stimulation on depression (Hamilton scale)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

KUBIS Nathalie, MD, PhD

Organizational Affiliation

Physiology Department, Hôpital Lariboisière, Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Physiology Department, Hôpital Lariboisière, Université Paris 7

City

Paris

State/Province

Ile de France

ZIP/Postal Code

75010

Country

France

12. IPD Sharing Statement

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

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