Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window

Not Applicable

Completed

Conditions: Ischemic Stroke

Registration Number: NCT00826059

Lead Sponsor: BrainsGate

Brief Summary: 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.

Detailed Description: A multi-center, multinational, randomized, blinded, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing Data Safety and Monitoring Board (DSMB) review of accumulated safety data.

Screening:

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 to:

* 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.

After implantation, active/sham stimulation will be administered in daily 4-hour sessions, beginning immediately following the placement procedure and continuing for 5 consecutive days.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1078

Inclusion Criteria

Age: Between 40 years and 80 years for male and 85 for female subjects
Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
Ability to initiate treatment within 8- 24 hours from stroke onset
Signed informed consent from patient him/herself or legally authorized representative if applicable

Exclusion Criteria

Intracranial hemorrhage or hemorrhagic transformation
Massive stroke
Acute ischemic stroke in the posterior circulation
Minor stroke
Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke
Previous stroke in the last 6 months or pre-existing disability
Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
Clinical signs and symptoms or imaging evidence of bilateral stroke.
Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
Known cerebral arteriovenous malformation, cerebral aneurysm.
Clinical suspicion of septic embolus.
Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
Serious systemic infection.
Women known to be pregnant or having a positive or indeterminate pregnancy test.
Patients with other implanted neural stimulator/ electronic devices (pacemakers).
Life expectancy < 1 year from causes other than stroke.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months	90 days±7 days	The primary efficacy endpoint is improvement beyond expectations on the modified Rankin Scale at 3 months (sliding dichotomy), assessed in primary populations of: 1. modified intention to treat (mITT) 2. confirmed cortical involvement (CCI), defined as baseline NIHSS ≥ 10 and signs of cortical involvement in baseline imaging (at least one of the following ASPECT regions: M1-M6, Insular Cortex) Type I Error is controlled at an overall level of 0.05 (two-sided) using the Hochberg method.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (73): Intercoastal Medical Group
🇺🇸
Sarasota, Florida, United States
Central DuPage Hospital
🇺🇸
Winfield, Illinois, United States
Guilford Neurologic Associates
🇺🇸
Greensboro, North Carolina, United States
University of Toledo Medical Center- Campus 1
🇺🇸
Toledo, Ohio, United States
University of Toledo Medical Center- Campus 2
🇺🇸
Toledo, Ohio, United States
Palmetto Health Richland
🇺🇸
Columbia, South Carolina, United States
Erlanger Stroke Center
🇺🇸
Chattanooga, Tennessee, United States
Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences
🇨🇦
Calgary, Canada
Department of Medicine, Stroke Program, University of Alberta Hospital
🇨🇦
Edmonton, Canada
University Hospital of Ostrava, Ostrava Poruba
🇨🇿
Poruba, Czechia
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Intercoastal Medical Group
🇺🇸Sarasota, Florida, United States