Impact of Peripheral Sensory Stimulation of the Hand in the Treatment of Stroke: A Preliminary Functional MRI Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke, Acute
- Sponsor
- NeuroGlove LLC
- Enrollment
- 13
- Primary Endpoint
- Rate of Adverse Events
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.)
Outcomes
Primary Outcomes
Rate of Adverse Events
Time Frame: 6 weeks
Rate and severity of adverse events related to the use of the NeuroGlove.
Brian Function
Time Frame: 6 weeks
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.
Secondary Outcomes
- Rankin Score(6 weeks)
- Motor Recovery(6 weeks)
- NIHSS score(6 weeks)
- Change in QOL(6 weeks)