Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT02928393
Eligibility Criteria:
Inclusion Criteria:
* Radiologic assessment confirming an acute middle cerebral artery ischemic stroke
* Index stroke occurred within the past 3-4 days
* Inpatient males and females
* Severe hemiparesis or hemiplegia defined by FMMS score less than or equal to (\</=) 35
* Sufficient speech, vision and hearing to participate in study evaluations
Exclusion Criteria:
* NIHSS greater than (\>) 20
* Severe aphasia that prevents a participant from following directions in rehabilitation
* Significant deficit from prior strokes or pre-existing motor deficit
* History of epilepsy, neurosurgery, severe head trauma or central nervous system infections that have residual symptomatology or have required treatment in the last 12 months
* Known or suspected clinical seizure post-index stroke
* History of pre-existing dementia or use of medications for dementia
* History of clinically significant pre-existing psychiatric conditions within 12 months prior to stroke
* Due to undergo carotid surgery within the next 4 months
* Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 6 times the half-life (whichever is longer)
* Clinically relevant medical conditions that would likely interfere with the study conduct and scheduled assessments
* Contraindication to magnetic resonance imaging (MRI) or conditions which render interpretation of MRI difficult
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02928393
Study Brief:
Protocol Section:
NCT02928393