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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
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.
Time frame: 6 weeks
Rate of Adverse Events
Rate and severity of adverse events related to the use of the NeuroGlove.
Time frame: 6 weeks
Motor Recovery
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
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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