NCT05961293

NeuroGlove fMRI Study

Impact of Peripheral Sensory Stimulation of the Hand in the Treatment of Stroke: A Preliminary Functional MRI Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: NeuroGlove LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ischemic Stroke, Acute
• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-15
• First posted: 2023-07-27
• Last updated: 2024-08-27