Status:
COMPLETED
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
Lead Sponsor:
BrainsGate
Conditions:
Ischemic Stroke
Eligibility:
All Genders
40-85 years
Phase:
NA
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 h...
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 accumula...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
1078 Patients enrolled
Trial Details
Trial ID
NCT00826059
Start Date
June 1 2011
End Date
June 1 2018
Last Update
February 24 2020
Active Locations (73)
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1
Intercoastal Medical Group
Sarasota, Florida, United States, 34239
2
Central DuPage Hospital
Winfield, Illinois, United States, 60190
3
Guilford Neurologic Associates
Greensboro, North Carolina, United States, 27401
4
University of Toledo Medical Center- Campus 1
Toledo, Ohio, United States, 43606