The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing DSMB review of accumulated safety data.
Since the treatment should be initiated within 24 hours from stroke onset, the screening window is limited and all procedures should be performed within this window.Subjects with Acute Ischemic Stroke will be screened upon arrival to the hospital. Since the treatment should be initiated between 8 and 24 hours from stroke onset, the screening window is limited and all procedures should be performed as soon as possible. All screened patients will be identified by patient number and will sign the informed consent prior to any study procedure initiation.
Period 1: Day 1-5
: Day 1- Eligible subjects will be randomized in a 1:1 (ISS Stimulation: Sham Control) ratio:
- Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of Care
- Group 2: Sham Implantation and Sham Stimulation during five consecutive days & Standard of Care Subjects will be transferred to the implantation procedure facility and the implantation/sham implantation will be performed by a trained physician.
Following implantation, stimulation/sham stimulation will be delivered. Day 2-4 ISS / Sham Stimulation will be repeated during the following four consecutive days by trained personnel within 18-26 hours from preceding stimulation.
Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed and the patients will be evaluated for safety and effectiveness.
Subjects will continue with Standard of Care as needed and will be released from the hospital upon investigator's judgment.
Period 2: Day of Discharge - 89±7 days During this period both groups (ISS Stimulation and Sham Control) will be treated according to Standard of Care either at the hospital, rehabilitation center or at home.
Scheduled visits will be performed on day 30±7 and day 60 ±7, which will include safety and effectiveness assessments.
Final Visit Day 90±7 days: The final visit will be performed at the study site and will include safety and effectiveness evaluations.
Patients will be contacted by study personnel via telephone on Day 180±7 and on Day 360±7 in order to assess their quality of life status.
- Ischemic Stroke System (ISS) Other
Intervention Desc: The latest generation of the ISS* neural-stimulator is an easy-to-use device for the treatment of acute ischemic stroke. It provides constant feedback to the medical staff regarding its proper operation and improves compliance with sphpepnopalatine ganglion (SPG) stimulation regimens.
- The Ischemic Stroke System Device
Intervention Desc: SPG stimulation and standard of care ARM 1: Kind: Experimental Label: 1 ARM 2: Kind: Experimental Label: Active Stimulation
- Sham control Device
Intervention Desc: Sham stimulation and standard of care ARM 1: Kind: Experimental Label: 2 ARM 2: Kind: Experimental Label: Sham Stimulation
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomized to one of two arms: 1)The Ischemic Stroke System or 2) Sham control. In addition to this all patients will be given standard of care for their stroke. At 90 days patients will be followed up using ordinal modified Rankin scale, Binary NIHSS, dichotomous modified Rankin scale and assessed for safety measures.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Distribution of patients across the ordinal modified Rankin scale (mRS); safety measurements across all study population.|
|Secondary||Binary NIHSS; dichotomous mRS.|
|Primary||Distribution of patients across the ordinal modified Rankin scale (mRS)||90 days||No|
|Primary||Safety measurements across all study population||90 days||Yes|
|Secondary||Binary NIHSS||90 days||No|
|Secondary||Dichotomous mRS||90 days||No|
|Secondary||Sliding Dichotomous mRS for subjects with aphasia at baseline||90 days||No|
|Secondary||Binary NIHSS (success for score ≤ 1 or for ≥ 9-point improvement versus baseline)||90 days||No|
- BrainsGate Lead