Aneurysmal Subarachnoid Hemorrhage
Conditions
Keywords
vasospasm, spinal cord stimulation, aneurysm, subarachnoid hemorrhage
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.
Interventions
DEVICEspinal cord stimulation
electrode is inserted into cervical epidural space for continuous spinal cord stimulation
Sponsors
Konstantin V. Slavin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of cerebral vasospasm | 14-17 days after aSAH |
Secondary
| Measure | Time frame |
|---|---|
| Any complication of spinal cord stimulation | up to 12 months |
Countries
United States
Outcome results
None listed