Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
Primary Purpose
Aneurysmal Subarachnoid Hemorrhage
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
spinal cord stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Aneurysmal Subarachnoid Hemorrhage focused on measuring vasospasm, spinal cord stimulation, aneurysm, subarachnoid hemorrhage
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
Sites / Locations
- University of Illinois Medical Center in Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
Spinal cord stimulation
Outcomes
Primary Outcome Measures
Prevention of cerebral vasospasm
Secondary Outcome Measures
Any complication of spinal cord stimulation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00766844
Brief Title
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
Official Title
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Konstantin V. Slavin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage
Keywords
vasospasm, spinal cord stimulation, aneurysm, subarachnoid hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Spinal cord stimulation
Intervention Type
Device
Intervention Name(s)
spinal cord stimulation
Intervention Description
electrode is inserted into cervical epidural space for continuous spinal cord stimulation
Primary Outcome Measure Information:
Title
Prevention of cerebral vasospasm
Time Frame
14-17 days after aSAH
Secondary Outcome Measure Information:
Title
Any complication of spinal cord stimulation
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantin V Slavin, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Medical Center in Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35920945
Citation
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.
Results Reference
derived
Learn more about this trial
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
We'll reach out to this number within 24 hrs