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NeuroGlove fMRI Study

Primary Purpose

Ischemic Stroke, Acute, Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NeuroGlove
Sponsored by
NeuroGlove LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Stroke, Ischemic Stroke, Acute Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control Cohort (Healthy Cohort)

    Treatment Arm

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Motor Recovery
    Evaluate the motor recovery of the affected upper extremity based on the change in hand grip strength from baseline using hand dynamometer
    NIHSS score
    Evaluate neurological recovery as measure by the change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline. The lower the score less severe the stroke symptoms.
    Rankin Score
    Evaluate functional recovery as measured by the modified Rankin Scale (mRS) score. A 0-6 scale is used to measure degree of ability 0 is no disability and 6 is death.
    Change in QOL
    Change in stroke-specific quality of life (SS-QOL) scores from baseline. Scale is 49-245 with higher scores indicating better function.

    Full Information

    First Posted
    July 18, 2023
    Last Updated
    September 21, 2023
    Sponsor
    NeuroGlove LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05961293
    Brief Title
    NeuroGlove fMRI Study
    Official Title
    Impact of Peripheral Sensory Stimulation of the Hand in the Treatment of Stroke: A Preliminary Functional MRI Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NeuroGlove LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: Control Cohort: 3 healthy volunteers 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke, Acute, Stroke
    Keywords
    Stroke, Ischemic Stroke, Acute Ischemic Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    13 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Cohort (Healthy Cohort)
    Arm Type
    Other
    Arm Description
    Healthy participants who participate in 1 study visit. The healthy participant will undergo one functional MRI which using the NeuroGlove.
    Arm Title
    Treatment Arm
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    NeuroGlove
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Brian Function
    Description
    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.
    Time Frame
    6 weeks
    Title
    Rate of Adverse Events
    Description
    Rate and severity of adverse events related to the use of the NeuroGlove.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Motor Recovery
    Description
    Evaluate the motor recovery of the affected upper extremity based on the change in hand grip strength from baseline using hand dynamometer
    Time Frame
    6 weeks
    Title
    NIHSS score
    Description
    Evaluate neurological recovery as measure by the change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline. The lower the score less severe the stroke symptoms.
    Time Frame
    6 weeks
    Title
    Rankin Score
    Description
    Evaluate functional recovery as measured by the modified Rankin Scale (mRS) score. A 0-6 scale is used to measure degree of ability 0 is no disability and 6 is death.
    Time Frame
    6 weeks
    Title
    Change in QOL
    Description
    Change in stroke-specific quality of life (SS-QOL) scores from baseline. Scale is 49-245 with higher scores indicating better function.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas Harold
    Phone
    612.255.0405
    Email
    tharold@neuroglove.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leslie Nussbaum
    Organizational Affiliation
    NeuroGlove LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan for sharing individual participants data to other researchers.

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    NeuroGlove fMRI Study

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