An interventional study of NeuroGlove in Ischemic Stroke, Acute and Stroke, sponsored by NeuroGlove LLC. Not yet recruiting. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by NeuroGlove LLC · Not applicable, Interventional, and Treatment
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:
Treatment Cohort: 10 subjects who have experienced mild to moderate stroke symptoms* that did not completely resolve after acute interventions.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 13 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →NeuroGlove LLC is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (control cohort):
Inclusion Criteria (treatment cohort):
Exclusion Criteria:
Healthy participants who participate in 1 study visit. The healthy participant will undergo one functional MRI which using the NeuroGlove.
Device: 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.
Device: NeuroGlove
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
No study locations are listed for this record.
Plan to share: No — There is no plan for sharing individual participants data to other researchers.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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