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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
Konstantin V. Slavin
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 3, 2008
Last Updated
January 21, 2013
Sponsor
Konstantin V. Slavin
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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

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Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

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