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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02132520
Eligibility Criteria:
Inclusion Criteria:
* 18-70 years of age
* Cortical or subcortical stroke with isolated unilateral motor paresis
* At least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician
* Impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension
* Able to ambulate at least 50 feet with minimal stand-by assistance
* Upper Extremity Fugl Meyer (Fugl-Meyer et al., 1975) score of greater than or equal to 20 out of 66
* Beck Depression Inventory (Beck et al., 1961) less than or equal to 19 out of 63
* Mini-mental State Examination score (Folstein et al., 1975) greater than or equal to 24 out of 30
* Must have an ipsilesional motor-evoked potential (MEP) in response to TMS
* Must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care
* Must be able to communicate clearly in English
* Must be able to provide consent in writing.
Exclusion Criteria:
* Personal history of epilepsy or seizures within the past 2 years
* Previous surgical procedure to the spinal cord
* Any MRI incompatible devices
* Pregnancy
* Claustrophobia
* Breathing disorder
* Hearing problems or ringing in the ears
* Bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
* Cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02132520
Study Brief:
Protocol Section:
NCT02132520