Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Sponsor
- Konstantin V. Slavin
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Prevention of cerebral vasospasm
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).
It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following aSAH.
Detailed Description
Continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). The single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm. The patients are followed for 12 months after completion of stimulation.
Investigators
Konstantin V. Slavin
Professor
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •Age 18-65
- •Subarachnoid hemorrhage (SAH) within 72 hours
- •Ruptured aneurysm confirmed by angiography of CT angiography
- •Fisher grade 2-4
- •Hunt \& Hess grade 2-4
- •Aneurysm is secured
- •Ability to obtain informed consent
Exclusion Criteria
- •Pregnancy
- •Allergy to IV contrast or to any component of SCS system
- •Non-aneurysmal SAH
- •Previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion
- •Coagulopathy
Outcomes
Primary Outcomes
Prevention of cerebral vasospasm
Time Frame: 14-17 days after aSAH
Secondary Outcomes
- Any complication of spinal cord stimulation(up to 12 months)