Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
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|ClinicalTrials.gov Identifier: NCT00766844|
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : January 23, 2013
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Spinal cord stimulation
Device: spinal cord stimulation
electrode is inserted into cervical epidural space for continuous spinal cord stimulation
- Prevention of cerebral vasospasm [ Time Frame: 14-17 days after aSAH ]
- Any complication of spinal cord stimulation [ Time Frame: up to 12 months ]
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
|United States, Illinois|
|University of Illinois Medical Center in Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Konstantin V Slavin, MD||University of Illinois at Chicago|