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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT01575366
Eligibility Criteria:
Inclusion criteria include:
* Ischemic stroke - due to higher risk of seizures in hemorrhagic stroke
* Subcortical location of stroke
* Stroke after 6 months - lower limit of 6 months to avoid confounding from spontaneous recovery (Jorgensen, Nakayama et al. 1995) and no upper limit to maximize pool of candidate subjects while still showing training effect (Carey, Kimberley et al. 2002)
* At least 18 years of age - to maximize pool of candidate subjects
* Mini-Mental State Examination score \>24 - to ensure satisfactory cognition to perform tasks
* Satisfactory corrected vision - to see computer screen during training and testing
* Active range of MP joint at paretic index finger of at least 10 degrees - based on minimal movement required to perform training task successfully, and that larger amplitudes would reduce the pool of subjects available for participating in the study.
* Ability to pronate the forearm so that index finger extension movement during training is vertically upward and relaxation results in the finger falling back to the flexed starting position
* not currently receiving any other therapy - to avoid confounding treatment effects
* Approval for participation by a neurologist - to ensure subject is reasonably safe to receive TMS testing. Subjects with proprioceptive loss or expressive aphasia will be included, providing they can carryout the training task.
Exclusion criteria include:
* Inability to follow 3-step commands
* A visual field cut that causes subjects not to see all indicators on a computer screen positioned centrally in from of them
* History of seizures
* Family member with history of seizures
* Presence of any other neuromuscular disorders
* Pregnancy
* Claustrophobia
* Indwelling metal or medical devices/implants incompatible with functional fMRI testing
* History of exposure to finger tracking training.
* Informed consent will be obtained and TMS/fMRI safety screenings will be conducted prior to testing procedures.
* Subjects will be recruited as volunteers from letters sent to previous research subjects inviting their participation, through visits to local stroke support groups meetings, newspaper advertisements and referrals from neurologists.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01575366
Study Brief:
Protocol Section:
NCT01575366