NCT01059149

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 16, 2015

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

January 28, 2010

Last Update Submit

January 15, 2015

Conditions

Nervous System DiseasesStrokeCerebrovascular DisordersBrain InfarctionBrain Ischemia

Keywords

RehabilitationTranscranial magnetic stimulationBrain magnetic stimulationRepetitiveStrokeSubacute

Outcome Measures

Primary Outcomes (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

    3 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

receive real rTMS

EXPERIMENTAL

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

sham rTMS

PLACEBO COMPARATOR

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

Interventions

repetitive transcranial magnetic stimulationDEVICE

MagPro x100 (MagVenture A/S, DANEMARK)

receive real rTMSsham rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiology Department, Hôpital Lariboisière, Université Paris 7

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Nervous System DiseasesStrokeCerebrovascular DisordersBrain InfarctionBrain Ischemia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • KUBIS Nathalie, MD, PhD

    Physiology Department, Hôpital Lariboisière, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 16, 2015

Record last verified: 2012-11

Locations

FR(1)