Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

Not Applicable

Completed

Conditions: Stroke

Interventions: Device: repetitive Transcranial Magnetic Stimulation -Off
Device: repetitive Transcranial Magnetic Stimulation -On

Registration Number: NCT02817087

Lead Sponsor: David Chiu, MD

Brief Summary: Transcranial magnetic stimulation for post-stroke upper-body motor deficits.

Detailed Description: This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved.

This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

Patients aged 18-80 years;
Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --

Exclusion Criteria

History of seizure;
Epileptogenic activity (indicative of increased risk of seizures) on EEG;
Any active unstable medical condition;
Pregnancy;
Schizophrenia, bipolar disorder, alcoholism, or substance abuse;
Medications which in the investigator's clinical judgment significantly lower the seizure threshold;
Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.;
Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study.
Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study
Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination:
National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction.
Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm.
Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm.
Any condition that precludes a high quality brain MRI scan.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repetitive Transcranial Magnetic Stimulation -Off	repetitive Transcranial Magnetic Stimulation -Off	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -On	repetitive Transcranial Magnetic Stimulation -On	Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.

Primary Outcome Measures

Name	Time	Method
Changes in Brain Activation	One business day before treatment begins, one business day after treatment ends, up to 5 weeks	Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI

Secondary Outcome Measures

Name	Time	Method
TUG (Timed Up and Go Test)	One business day before treatment begins, one business day after treatment ends up to 5 weeks	Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.
National Institutes of Health Stroke Scale (NIHSS)	One business day before treatment begins, one business day after treatment ends up to 5 weeks	Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome
ARAT (Action Research Arm Test)	One business day before treatment begins, one business day after treatment ends up to 5 weeks	Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome
Hand Dynamometer	One business day before treatment begins, one business day after treatment ends up to 5 weeks	Change in grip strength The higher the number represents better outcome
Fugl-Meyer Motor Arm Score	One business day before treatment begins, one business day after treatment ends up to 5 weeks	Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome
Pinch Dynamometer Score	One business day before treatment begins, one business day after treatment ends up to 5 weeks	Change in pinch strength. The higher the number, the better the outcome.