NeuroGlove fMRI Study

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05961293
• Lead Sponsor: NeuroGlove LLC

Brief Summary

This is a prospective, single center, interventional clinical study containing two cohorts the treatment cohort and control cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the control cohort and undergo imaging only. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will receive treatment using the NeuroGlove.

Detailed Description

This is a prospective, single center, interventional clinical study containing two cohorts the treatment cohort and control cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the control cohort and undergo imaging only. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will receive treatment using the NeuroGlove.

Up to 13 subjects enrolled and complete study procedures. There will be 2 cohorts enrolled in the study:

1. Control Cohort: 3 healthy volunteers

2. Treatment 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 NIHSSS score of 3 to 15.

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Status Verified: 2023-11
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2024-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13

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 healthy participant will undergo one functional MRI which using the NeuroGlove.
Treatment Arm	NeuroGlove	The treatment cohort will undergo two functional MRIs once at baseline and the final fMRI will occur six weeks after initial study visit after daily use of the NeuroGlove.

Primary Outcome Measures

Name	Time	Method
Rate of Adverse Events	6 weeks	Rate and severity of adverse events related to the use of the NeuroGlove.
Brian Function	6 weeks	Evaluate brain function through a fMRI assessing post-stroke changes in brain activation including functional recruitment of new brain territories in subjects undergoing rehabilitation with the NeuroGlove.

Secondary Outcome Measures

Name	Time	Method
Rankin Score	6 weeks	Evaluate functional recovery as measured by the modified Rankin Scale (mRS) score. A 0-6 scale is used to measure degree of ability 0 is no disability and 6 is death.
Motor Recovery	6 weeks	Evaluate the motor recovery of the affected upper extremity based on the change in hand grip strength from baseline using hand dynamometer
NIHSS score	6 weeks	Evaluate neurological recovery as measure by the change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline. The lower the score less severe the stroke symptoms.
Change in QOL	6 weeks	Change in stroke-specific quality of life (SS-QOL) scores from baseline. Scale is 49-245 with higher scores indicating better function.