Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJanuary 23, 2013
January 1, 2013
7 months
October 3, 2008
January 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of cerebral vasospasm
14-17 days after aSAH
Secondary Outcomes (1)
Any complication of spinal cord stimulation
up to 12 months
Study Arms (1)
Active
EXPERIMENTALSpinal cord stimulation
Interventions
electrode is inserted into cervical epidural space for continuous spinal cord stimulation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois Medical Center in Chicago
Chicago, Illinois, 60612, United States
Related Publications (1)
Slavin KV, Vannemreddy P. Cervical spinal cord stimulation for prevention and treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage: clinical and radiographic outcomes of a prospective single-center clinical pilot study. Acta Neurochir (Wien). 2022 Nov;164(11):2927-2937. doi: 10.1007/s00701-022-05325-4. Epub 2022 Aug 3.
PMID: 35920945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Konstantin V Slavin, MD
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2009
Last Updated
January 23, 2013
Record last verified: 2013-01