Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke
Completed · Not applicable · Has a placebo group
Conditions studied: Stroke
In brief
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
Key facts
- Study ID
- NCT02817087
- Run by
- David Chiu, MD
- People needed
- 38
- Starts
- 2016-05-27
- Expected to finish
- 2019-03-13
- Last updated by the study team
- 2020-10-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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; --
You may not qualify if…
- 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.
Where it is running
- Houston Methodist Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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