Status:
COMPLETED
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
Lead Sponsor:
Konstantin V. Slavin
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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)....
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00766844
Start Date
April 1 2008
End Date
November 1 2009
Last Update
January 23 2013
Active Locations (1)
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1
University of Illinois Medical Center in Chicago
Chicago, Illinois, United States, 60612