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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).
Kutaisi Referral Hospital
Kutaisi, Georgia
Rustavi Central Hospital
Rustavi, Georgia
First University Clinic
Tbilisi, Georgia
Zugdidi Referral Hospital
Zugdidi, Georgia
NIHSS Assessment
The difference in NIHSS between baseline and Day 7 vs. Historical Controls (the historical controls are patients in the control arm in the NINDS trial)
Time frame: Day 7
% of patients with improvement in stroke symptoms during stimulation
Assessment of improvement in stroke symptoms (motor and/or sensory deficits) before and during stimulation at the Personal Stimulation Level, using a hand dynamometer (Baseline Hydraulic Hand Dynamometers, Fabrication Enterprises Inc, White Plains NY, USA).
Time frame: Day 2-5
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