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Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Konstantin V. Slavin, University of Illinois
ClinicalTrials.gov Identifier:
NCT00766844
First received: October 3, 2008
Last updated: January 21, 2013
Last verified: January 2013
History of Changes

October 3, 2008
January 21, 2013
April 2008
November 2008   (final data collection date for primary outcome measure)
Prevention of cerebral vasospasm [ Time Frame: 14-17 days after aSAH ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00766844 on ClinicalTrials.gov Archive Site
Any complication of spinal cord stimulation [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Aneurysmal Subarachnoid Hemorrhage
Device: spinal cord stimulation
electrode is inserted into cervical epidural space for continuous spinal cord stimulation
Experimental: Active
Spinal cord stimulation
Intervention: Device: spinal cord stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00766844
UIC 2007-0899, FDA IDE G060177/S001
Yes
Konstantin V. Slavin, University of Illinois
Konstantin V. Slavin
Not Provided
Principal Investigator: Konstantin V Slavin, MD University of Illinois
University of Illinois
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP