Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

Konstantin V. Slavin

Status and phase

Completed

Phase 1

Conditions

Aneurysmal Subarachnoid Hemorrhage

Treatments

Device: spinal cord stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00766844

FDA IDE G060177/S001 (Other Identifier)

UIC 2007-0899

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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