Phase
Condition
Stroke
Cerebral Ischemia
Treatment
Sham vibrotactile coordinated reset
Active Vibrotactile coordinated reset
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age at the time of enrollment: 18-80 years
Diagnosis of ischemic or hemorrhagic stroke
Disease period of more than 6 months
Mini Mental State Examination of at least 24 points
No medications that affect balance
Motor deficit
Use of Motricity Arm and Leg index to include impaired individuals with somefunctioning
Modified Rankin Scale for Neurologic Disability: Scores 3 or 4
Exclusion
Exclusion Criteria:
Any significant psychiatric problems, including acute confusional state (delirium),ongoing psychosis, or clinically significant depression
Any current drug or alcohol abuse
History of recurrent or unprovoked seizures
Any neurological disorder treatments that involve intracranial surgery or deviceimplantation
Participation in another drug, device or biologic trial concurrently or within thepreceding days
Pregnancy, breastfeeding or wanting to become pregnant during the trial
History or presence of other major neurological or orthopedic diseases other thanstroke that limits motor functioning or cognitive ability
More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, orankle
Botox, baclofen or any other treatment for spasticity except for bracing orsplinting within the previous 3 months
Must be able to communicate with staff
Severe sensory abnormalities of the fingers such as vibratory urticaria
Study Design
Connect with a study center
Stanford University
Stanford, California 94303
United StatesSite Not Available
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