Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766844
• Other study ID #: UIC 2007-0899
• Secondary ID: FDA IDE G060177/
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2008
• Last updated: January 21, 2013
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2013
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• spinal cord stimulation
electrode is inserted into cervical epidural space for continuous spinal cord stimulation

Locations

Country	Name	City	State
United States	University of Illinois Medical Center in Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Konstantin V. Slavin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of cerebral vasospasm		14-17 days after aSAH	No
Secondary	Any complication of spinal cord stimulation		up to 12 months	Yes