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

Completed · Not applicable · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT00826059

Run by

BrainsGate

People needed

1078

Starts

2011-06-01

Expected to finish

2018-06-01

Last updated by the study team

2020-02-24

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• General University Hospital — Prague, Czechia
• Vitkovicka nemocnice a.s. Ostrava Vitkovice — Vítkovice, Czechia
• Aarhus University Hospital — Aarhus, Denmark
• Helsinki University Hospital — Helsinki, Finland
• Kuopio University Hospital — Kuopio, Finland
• Hospital de la Cavale Blanche — Brest, France
• Hospital Nord Laennec — Nantes, France
• Hospital Saint Roch — Nice, France
• Hopital Lariboisiere — Paris, France
• Hospital Pontchaillou — Rennes, France
• Unimed Adjara Batumi Referral Hospital — Batumi, Georgia
• Kutaisi Referral Hospital — Kutaisi, Georgia
• Rustavi Central Hospital — Rustavi, Georgia
• Emergency Neurology Clinic Neurology Ltd. — Tbilisi, Georgia
• First University Clinic — Tbilisi, Georgia
• Intercoastal Medical Group — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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