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

August 26, 2024 updated by: NeuroGlove LLC
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Up to13 subjects will be enrolled and complete study procedures. There will be 2 study cohorts enrolled in the study:

  1. Healthy Cohort: 3 healthy volunteers (enrolled from the general population)
  2. Post Stroke 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 NIHSS score of 5 to 15.)

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Cohort (Healthy Cohort)
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
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.
Active Comparator: Treatment Arm
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Function
Time Frame: 2 hours
Evaluate brain function through a functional MRI (fMRI) in both healthy subjects (without history of stroke) and post stroke patients.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroGlove LLC

Investigators

  • Study Director: Eric Nussbaum, MD, NeuroGlove LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2024

Primary Completion (Estimated)

November 14, 2024

Study Completion (Estimated)

November 15, 2024

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-1005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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