Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study
Cerebral vasospasm is characterized by a vasoconstriction of cerebral arteries causing a reduction of cerebral blood flow (CBF) and leading to ischemia and infarction of the brain parenchyma. Cerebral vasospasm is a serious complication of aneurysmal subarachnoid hemorrhage (SAH) with high morbidity and overall mortality of 40-50%. Although the exact mechanisms of spinal cord stimulation (SCS) on the innervation of cerebral vessels are still unclear, several hypotheses have been formulated and studies in animals and human performed with very promising results. This is a proof of concept study to better understand the effect and mechanisms of cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH in human.
• Fisher 3 grade subarachnoid hemorrhage at presentation
• Secured aneurysm by clipping or coiling
• Is 18-75 years of age at the time of enrollment
• Cerebral vasospasm:
‣ Cerebral angiography
‣ o Narrowing of vessel lumen \> 66%
⁃ Transcranial Doppler ultrasound
• Mean flow velocity \> 150 cm/s or
∙ Lindegaard Index \> 3 or
∙ increase \> 50 cm/s within 24 hours
⁃ Intracranial CT angiography
‣ o Narrowing of vessel lumen \> 66%
⁃ Intracranial CT perfusion o Time To Drain (TTD) \> 4.7 seconds
• Is willing and capable of providing informed consent or existence of the presumed will of the patient by a relative or a legal representative
• Written confirmation by a study independent physician to guarantee patient interest
• Is willing and capable of complying with the study related requirements, procedures, and visits
• No findings on spinal imaging preventing SCS lead implantation
• Negative pregnancy test
• No breast feeding