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:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT04312269
Eligibility Criteria:
Inclusion Criteria:
* Age at enrollment is 21 or older
* Hemiparesis from first ever stroke affecting arm movement at least 6 months prior to screening
* Severe to moderate motor impairment (FMA-UE of 7-40)
* At least some voluntary shoulder and elbow muscle activation
Exclusion Criteria:
* Inability to follow instructions of the MyoCI task
* Visual impairment (such as hemianopia) preventing full view of screen
* Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest)
* Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
* Inability to understand or follow commands in English due to aphasia or other reason
* Diffuse or multifocal infarcts in both hemispheres
* Substantial arm pain preventing participation for 90 minutes a day
* Spasticity treatment (pharmacological or Botox) within last 3 months
* Ferromagnetic implants that are MRI incompatible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
100 Years
Study:
NCT04312269
Study Brief:
Protocol Section:
NCT04312269