Clinical trial NCT05961293: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke, Acute
Stroke
Keywords: Stroke
Ischemic Stroke
Acute Ischemic Stroke
Lead sponsor: NeuroGlove LLC
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Brian Function
timeFrame: 6 weeks
measure: Rate of Adverse Events
timeFrame: 6 weeks
Secondary outcomes:
measure: Motor Recovery
timeFrame: 6 weeks
measure: NIHSS score
timeFrame: 6 weeks
measure: Rankin Score
timeFrame: 6 weeks
measure: Change in QOL
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: NeuroGlove LLC
name: Leslie Nussbaum
role: PRINCIPAL_INVESTIGATOR
References: