Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

Phase 1

Completed

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Device: spinal cord stimulation

• Registration Number: NCT00766844
• Lead Sponsor: Konstantin V. Slavin

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Primary Completion: 2008-11
• Study Completion: 2009-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	spinal cord stimulation	Spinal cord stimulation

Primary Outcome Measures

Name	Time	Method
Prevention of cerebral vasospasm	14-17 days after aSAH

Secondary Outcome Measures

Name	Time	Method
Any complication of spinal cord stimulation	up to 12 months

Trial Locations

Locations (1)

University of Illinois Medical Center in Chicago; 🇺🇸 Chicago, Illinois, United States