NeuroGlove fMRI Study

NeuroGlove

Status: Not yet enrolling

Conditions: Stroke; Ischemic Stroke, Acute

Treatments: Device: NeuroGlove

Study type: Interventional

Funder types: Industry

Identifiers

NCT05961293

REG-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (control cohort):

• Able and willing to provide informed consent.
• Men and women ≥18 and <85 years of age.
• Subject must be right hand dominant.
• Subject should not have any physical limitations of either upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)

Inclusion Criteria (treatment cohort):

• Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
• Men and women ≥18 and <85 years of age.
• First single acute ischemic stroke with an onset date within 14 days (± 7 days from onset) of enrollment (time of informed consent) into the study.
• Mild to moderate acute ischemic stroke defined as NIHSS score of 3 to 15.
• Measurable weakness of one upper extremity without complete paralysis (detectable movement in at least 3 fingers).
• Subject must be right hand dominant.

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.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Control Cohort (Healthy Cohort)

Other group

Description:

Healthy participants who participate in 1 study visit. The healthy participant will undergo one functional MRI which using the NeuroGlove.

Treatment:

Device: NeuroGlove

Treatment Arm

Experimental group

Description:

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.

Treatment:

Device: NeuroGlove