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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07439367
Eligibility Criteria:
Inclusion Criteria:
For Stroke Participants:
* Age ≥ 18 years
* First-ever ischemic or hemorrhagic stroke
* Time since stroke ≥ 6 months
* Unilateral upper limb hemiparesis
* Fugl-Meyer Assessment Upper Extremity (FMA-UE) score between 29 and 57
* Modified Ashworth Scale score \< 2 at elbow, wrist, or finger flexors
* Manual muscle testing ≥ 3/5 in proximal upper limb muscles (deltoid, biceps, triceps, wrist pronators/supinators)
* Ability to understand and follow study procedures
* Provided written informed consent
For Healthy Participants:
* Age ≥ 18 years
* No history of neurological disease
* Ability to understand and follow study procedures
* Provided written informed consent
Exclusion Criteria:
For Stroke Participants:
* Second stroke occurring during the study period
* Botulinum toxin injection within 3 months prior to study start
* History of one or more epileptic seizures
* Metallic object near the stimulation site
* Implanted electronic or metallic devices (e.g., pacemaker, neurostimulator) incompatible with TMS
* Severe comorbid conditions affecting the upper limb (traumatic, rheumatologic, osteoarticular, or neurodegenerative disorders)
* Pregnancy
* Delirium or impaired vigilance
* Inability to participate in one-hour treatment sessions
* Inability to comply with study procedures (e.g., language barrier, psychological disorder, dementia)
* Current or past substance abuse, including excessive alcohol consumption
* Participation in another interventional clinical trial within 30 days prior to enrollment
For Healthy Participants:
* Severe musculoskeletal or neurological condition affecting the non-dominant upper limb
* Pregnancy
* Delirium or impaired vigilance
* Inability to participate in one-hour treatment sessions
* Inability to comply with study procedures
* Current or past substance abuse, including excessive alcohol consumption
* Participation in another interventional clinical trial within 30 days prior to enrollment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07439367
Study Brief:
Protocol Section:
NCT07439367