Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

David Chiu, MD

Status: Completed

Conditions: Stroke

Treatments: Device: repetitive Transcranial Magnetic Stimulation -Off; Device: repetitive Transcranial Magnetic Stimulation -On

Study type: Interventional

Funder types: Other

Identifiers

NCT02817087

Pro00014213

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups

repetitive Transcranial Magnetic Stimulation -On

Active Comparator group

Description:

Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation -On

repetitive Transcranial Magnetic Stimulation -Off

Sham Comparator group

Description:

Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation -Off