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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Cohort (Healthy Cohort) | Other | Healthy participants who participate in 1 study visit. The healthy participant will undergo one functional MRI which using the NeuroGlove. |
|
| Treatment Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroGlove | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Rate of Adverse Events | Rate and severity of adverse events related to the use of the NeuroGlove. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Recovery | Evaluate the motor recovery of the affected upper extremity based on the change in hand grip strength from baseline using hand dynamometer | 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. |
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Inclusion Criteria (control cohort):
Inclusion Criteria (treatment cohort):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Harold | Contact | 612.255.0405 | tharold@neuroglove.net |
| Name | Affiliation | Role |
|---|---|---|
| Leslie Nussbaum | NeuroGlove LLC | Principal Investigator |
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There is no plan for sharing individual participants data to other researchers.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. | 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. | 6 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |