Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT03551093
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)
Sponsor:
BrainsGate
Organization:
Study Overview
Official Title:
A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic Stroke System (ISS), as an Adjunct to Standard of Care in Subjects With Mild Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
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:
ImpACT-24M
Brief Summary:
Study Population:
Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.
Study objectives:
1. Identify the personal stimulation level for each patient based on physiological biomarkers
2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level
Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.
Study objectives:
1. Identify the personal stimulation level for each patient based on physiological biomarkers
2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level
Detailed Description:
A Multicenter, Single Arm Trial to Assess Safety and Signal of Efficacy of the Ischemic Stroke System (ISS), as an Adjunct to Standard of Care in Subjects with Mild Acute Ischemic Stroke
Study Duration:
The expected total duration of the study for each subject is up to 10 days as follows:
Enrollment: up to 24 hours Treatment: Implantation, 5 Days of SPG stimulation and Standard of care Final Visit: 7 days after enrollment
Study Population:
Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.
Study Objectives:
1. Identify the personal stimulation level for each patient based on physiological biomarkers
2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level
Study Design:
This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps:
1. Screening (day 1)
2. Implantation (day 1)
3. Treatment and symptom assessment (days 1-5)
4. Device Positioning and Removal (day 5)
5. Discharge/Final Visit (day 7-10)
Outcome Measures:
Primary Outcome Measures:
1. The difference in NIHSS between baseline and Day 7 vs. Historical Controls
2. % of patients with improvement in stroke symptoms (motor and/or sensory deficits) during stimulation
Additional Efficacy Outcome Measures:
1. Existence of physiologic surrogates of the Personal Stimulation Level
2. Improvement in stroke symptoms (motor and/or sensory deficits)
Safety Outcome Measures:
1. Comparative 7-day safety data between the ISS stimulation group of this study and of the ImpACT-24B study:
1. Incidence of Serious Adverse Events
2. Implantation Complications
3. Stimulation-related Adverse Events
2. 7-day mortality
3. Neurological deterioration
4. Symptomatic intracranial hemorrhage (sICH)
Implantation Accuracy Outcome Measures:
1\. % of procedures with positive indication of reaching the sphenopalatine fossa
Study Duration:
The expected total duration of the study for each subject is up to 10 days as follows:
Enrollment: up to 24 hours Treatment: Implantation, 5 Days of SPG stimulation and Standard of care Final Visit: 7 days after enrollment
Study Population:
Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset.
Study Objectives:
1. Identify the personal stimulation level for each patient based on physiological biomarkers
2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level
Study Design:
This will be a multi-center, adjunctive to Standard of Care, single arm study, which includes the following steps:
1. Screening (day 1)
2. Implantation (day 1)
3. Treatment and symptom assessment (days 1-5)
4. Device Positioning and Removal (day 5)
5. Discharge/Final Visit (day 7-10)
Outcome Measures:
Primary Outcome Measures:
1. The difference in NIHSS between baseline and Day 7 vs. Historical Controls
2. % of patients with improvement in stroke symptoms (motor and/or sensory deficits) during stimulation
Additional Efficacy Outcome Measures:
1. Existence of physiologic surrogates of the Personal Stimulation Level
2. Improvement in stroke symptoms (motor and/or sensory deficits)
Safety Outcome Measures:
1. Comparative 7-day safety data between the ISS stimulation group of this study and of the ImpACT-24B study:
1. Incidence of Serious Adverse Events
2. Implantation Complications
3. Stimulation-related Adverse Events
2. 7-day mortality
3. Neurological deterioration
4. Symptomatic intracranial hemorrhage (sICH)
Implantation Accuracy Outcome Measures:
1\. % of procedures with positive indication of reaching the sphenopalatine fossa
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?: