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Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00766844
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Konstantin V. Slavin, University of Illinois at Chicago

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.


Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Device: spinal cord stimulation Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510
Study Start Date : April 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Active
Spinal cord stimulation
Device: spinal cord stimulation
electrode is inserted into cervical epidural space for continuous spinal cord stimulation




Primary Outcome Measures :
  1. Prevention of cerebral vasospasm [ Time Frame: 14-17 days after aSAH ]

Secondary Outcome Measures :
  1. Any complication of spinal cord stimulation [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766844


Locations
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United States, Illinois
University of Illinois Medical Center in Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Konstantin V. Slavin
Investigators
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Principal Investigator: Konstantin V Slavin, MD University of Illinois at Chicago

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Responsible Party: Konstantin V. Slavin, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00766844     History of Changes
Other Study ID Numbers: UIC 2007-0899
FDA IDE G060177/S001 ( Other Identifier: FDA )
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by Konstantin V. Slavin, University of Illinois at Chicago:
vasospasm
spinal cord stimulation
aneurysm
subarachnoid hemorrhage

Additional relevant MeSH terms:
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Brain Diseases
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases