Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm - Full Text View

Sponsored by:	University of Illinois
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00766844

Purpose

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	Intervention	Phase
Aneurysmal Subarachnoid Hemorrhage	Device: spinal cord stimulation	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510

Further study details as provided by University of Illinois:

Primary Outcome Measures:

Prevention of cerebral vasospasm [ Time Frame: 14-17 days after aSAH ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Any complication of spinal cord stimulation [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental Clinical group of patients undergoing stimulation	Device: spinal cord stimulation electrode is inserted into cervical epidural space for continuous stimulation of the spinal cord

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766844

Locations

United States, Illinois
University of Illinois Medical Center in Chicago
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

University of Illinois

Investigators

Principal Investigator:

Konstantin V Slavin, MD

University of Illinois

More Information

Responsible Party:	University of Illinois at Chicago ( Konstantin Slavin, MD, Associate Professor of Neurosurgery )
Study ID Numbers:	UIC 2007-0899, FDA IDE G060177/S001
Study First Received:	October 3, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00766844
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Illinois:

vasospasm
spinal cord stimulation
aneurysm
subarachnoid hemorrhage

Study placed in the following topic categories:

Aneurysm
Vascular Diseases
Subarachnoid Hemorrhage
Central Nervous System Diseases
Intracranial Hemorrhages

Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Vasospasm, Intracranial

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009