NeuroGlove fMRI Study

NCT ID: NCT05961293

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2024-12-15

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.

Conditions

Ischemic Stroke, Acute; Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Cohort (Healthy Cohort)

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

Group Type: OTHER

NeuroGlove

Intervention Type: DEVICE

NeuroGlove is a non-invasive device that provides peripheral somatosensory stimulation to the hand of a stroke victim during acute, subacute, or chronic phases of a stroke. NeuroGlove provides sensory stimulation in the forms of pneumatic puffs of air. There is some early evidence that early peripheral sensory stimulation may improve neurological outcomes following an ischemic stroke.

Treatment Arm

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.

Group Type: EXPERIMENTAL

NeuroGlove

Intervention Type: DEVICE

NeuroGlove is a non-invasive device that provides peripheral somatosensory stimulation to the hand of a stroke victim during acute, subacute, or chronic phases of a stroke. NeuroGlove provides sensory stimulation in the forms of pneumatic puffs of air. There is some early evidence that early peripheral sensory stimulation may improve neurological outcomes following an ischemic stroke.

Interventions

NeuroGlove

NeuroGlove is a non-invasive device that provides peripheral somatosensory stimulation to the hand of a stroke victim during acute, subacute, or chronic phases of a stroke. NeuroGlove provides sensory stimulation in the forms of pneumatic puffs of air. There is some early evidence that early peripheral sensory stimulation may improve neurological outcomes following an ischemic stroke.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.)

• 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NeuroGlove LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Nussbaum

Role: PRINCIPAL_INVESTIGATOR

NeuroGlove LLC

Central Contacts

Thomas Harold

Role: CONTACT

tharold@neuroglove.net

612.255.0405

Other Identifiers

REG-1001

Identifier Type: -

Identifier Source: org_study_id