NeuroGlove fMRI Study

NCT05961293 | Unknown

• 1 other identifier: REG-1001
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke, Acute; Stroke

Keywords

Stroke; Ischemic Stroke; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Brian Function

  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.

  6 weeks

• Rate of Adverse Events

  Rate and severity of adverse events related to the use of the NeuroGlove.

  6 weeks

Secondary Outcomes (4)

• Motor Recovery

  6 weeks

• NIHSS score

  6 weeks

• Rankin Score

  6 weeks

• Change in QOL

  6 weeks

Study Arms (2)

Control Cohort (Healthy Cohort)

OTHER

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

Device: NeuroGlove

Treatment Arm

EXPERIMENTAL

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.

Device: NeuroGlove

Interventions

NeuroGlove 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.

Control Cohort (Healthy Cohort); Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• NeuroGlove LLC: lead

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leslie Nussbaum

  NeuroGlove LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Harold

CONTACT

612.255.0405; tharold@neuroglove.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: August 27, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share