Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke



Status:Enrolling by invitation
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:April 2016
End Date:March 13, 2019

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An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator

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

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.

Inclusion Criteria:

- Patients aged ≥ 18 years;

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

- Patients may be on medications for the treatment of stroke or comorbidities provided
the medication regimen is stable for six weeks prior to inclusion in the study and
remains unchanged for the duration of the study.

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 body, including pacemakers,
defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the
eyes, etc.; and

- Any changes in medications prescribed for the treatment of stroke or comorbidities six
weeks prior to inclusion in the study or at any time during the study.

- Treatment with botulinum toxin in the two months prior to treatment or any planned
treatment with botulinum toxin in the period of the treatment

- Neurological condition not stable - clinically significant changes in NIHSS,
Fugl-Meyer score, or ARAT score between Visits 1 and 2 (treatment begins at Visit 3)
We found this trial at
1
site
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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mi
from
Houston, TX
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