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

NCT06573840 | Withdrawn

• 1 other identifier: REG-1005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke; Stroke; Acute Ischemic Stroke

Keywords

Stroke; Ischemic Stroke; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Brain Function

  Evaluate brain function through a functional MRI (fMRI) in both healthy subjects (without history of stroke) and post stroke patients.

  2 hours

Study Arms (2)

Control Cohort (Healthy Cohort)

ACTIVE COMPARATOR

Healthy participants who participate in 1 study visit. The unhealthy participant will undergo one functional MRI before, during and after a NeuroGlove session.

Device: NeuroGlove

Treatment Arm

ACTIVE COMPARATOR

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.

Device: NeuroGlove

Interventions

NeuroGlove DEVICE

NeuroGlove is a non-invasive device that provides peripheral somatosensory stimulation to the hand. NeuroGlove provides sensory stimulation in the form of pneumatic puffs of air.

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. Subject should not have any physical limitations of either upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)

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

• Eric Nussbaum, MD

  NeuroGlove LLC

  STUDY DIRECTOR

Study Design

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

Model Details: 3 healthy volunteers and 10 post stroke patients will be enrolled in the study.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: August 27, 2024
• Study Start: November 10, 2024
• Primary Completion: November 14, 2024
• Study Completion: November 15, 2024
• Last Updated: August 27, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share