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 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
NCT ID:
NCT02268461
Eligibility Criteria:
Inclusion Criteria:
1. first-time stroke
2. stroke at least six months prior to onset of study with chronic sequela of spasticity
3. stroke location- either cortical or subcortical
4. stroke type- either hemorrhagic or ischemic
5. stroke hemisphere- either left or right, dominant or non- dominant hemisphere
6. 18 years of age or older
7. gender- either male or female
8. ability to follow three-step directions
9. demonstration of 10 degrees of active extension at the metacarpophalangeal joint and wrist of the paretic upper extremity
10. demonstration of consistent resting motor evoked potential from ipsilesional and contralesional hemispheres
11. sufficient ambulation or wheelchair mobility to allow subject to present to treatment and testing areas with minimum assist
Exclusion Criteria:
1. history of seizure within the past two years
2. inability to follow three-step directions
3. anosognosia
4. moderate to severe receptive aphasia
5. inability to give informed consent
6. premorbid spasticity or neurologic impairment prior to stroke
7. co-morbidities impairing upper extremity function such as fracture or deformity
8. indwelling metal or medical devices incompatible with TMS
9. pregnancy
10. bi-hemispheric or multifocal stroke
11. dementia
12. neurolytic injection within the 3 months prior to onset of study or planned neurolytic injection during study period
13. planned vacation or travel during study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02268461
Study Brief:
Protocol Section:
NCT02268461