Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT05961293
Status:
UNKNOWN
Last Update Posted:
2024-08-27
First Post:
2023-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NeuroGlove fMRI Study
Sponsor:
NeuroGlove LLC
Organization:
Study Overview
Official Title:
Impact of Peripheral Sensory Stimulation of the Hand in the Treatment of Stroke: A Preliminary Functional MRI Study
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: