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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT06979466
Eligibility Criteria:
Inclusion Criteria:
* FMA-UE score between 22-50 (inclusive) of impaired limb.
* Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.
* Age 18 to 80 years of age (inclusive).
* Stroke due to ischemia or to intracerebral hemorrhage.
* \>6 months to 5 years from index stroke onset.
* Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
* Able to sit with the investigational System for 40 consecutive minutes.
* Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent.
* Willingness to participate in physical exercises during study intervention sessions.
* Availability of a relative or other caregiver able to assist during study treatment sessions and visits.
* If female, not pregnant or breastfeeding or planning pregnancy during the study period.
* Informed consent signed by subject.
Exclusion Criteria:
* Severe neglect impairment interfering with assessments or treatments.
* Severe depression, defined as GDS Score \>10/15
* The presence of MR-incompatible implanted devices or MR-incompatible retained objects; or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).
* Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years
* Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
* Severe UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
* Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
* Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
* Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
* Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
* Participation in another interventional trial that would conflict with the current study or clinical endpoint interference may occur.
* Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.
* Employee of the Sponsor.
* Prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06979466
Study Brief:
Protocol Section:
NCT06979466