A Functional MRI Study: Assessing Brain Function in Post Stoke Patients

NeuroGlove LLC0 sitesNovember 10, 2024

Overview

Brief Summary

This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort.

Detailed Description

This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort. Up to13 subjects will be enrolled and complete study procedures. There will be 2 study cohorts enrolled in the study: 1. Healthy Cohort: 3 healthy volunteers (enrolled from the general population) 2. Post Stroke Cohort: 10 subjects who have experienced mild to moderate stroke symptoms that did not completely resolve after acute interventions. (Mild to moderate stroke symptoms is defined as a NIHSS score of 5 to 15.)

Registry

clinicaltrials.gov

Start Date

November 10, 2024

End Date

November 15, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NeuroGlove LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Coma, inability to cooperate with the study based on impaired level of consciousness or confusion.
•Known neurological deficit prior to stroke (including but not limited to previous stroke, MS, Parkinson's disease).
•Physical limitations of the weak upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.) Any contraindication to the imaging required per the protocol. Complete middle cerebral artery infarction based on imaging. Carotid artery stenosis \>50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).
•Subjects has a known history of substance abuse (drug) or alcohol dependence, or lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
•If female, subject is pregnant at the time of enrollment or planning to become pregnant during the trial period.
•Subject has any other acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures.
•Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)