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

Not Applicable

Withdrawn

• Conditions: Acute Ischemic Stroke; Stroke; Ischemic Stroke
• Interventions: Device: NeuroGlove

• Registration Number: NCT06573840
• Lead Sponsor: NeuroGlove LLC

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.)

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Study Start: 2024-11-10
• Primary Completion: 2024-11-14
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Cohort (Healthy Cohort)	NeuroGlove	Healthy participants who participate in 1 study visit. The unhealthy participant will undergo one functional MRI before, during and after a NeuroGlove session.
Treatment Arm	NeuroGlove	The treatment cohort which consists of patients who have experienced an acute ischemic stroke will participate in 1 study visit. They will undergo 1 function MRI before, during and after a NeuroGlove session.

Primary Outcome Measures

Name	Time	Method
Brain Function	2 hours	Evaluate brain function through a functional MRI (fMRI) in both healthy subjects (without history of stroke) and post stroke patients.