Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Dec 7, 2021

Keywords

ClinConnect Summary

The VasoStim Study is a clinical trial exploring the effects of cervical spinal cord stimulation (SCS) on patients experiencing cerebral vasospasm after a type of brain bleed known as subarachnoid hemorrhage (SAH). Cerebral vasospasm happens when the blood vessels in the brain narrow, reducing blood flow and potentially causing serious complications. This study aims to better understand how SCS might help improve blood flow in these patients.

To participate in this trial, individuals must be between 18 and 75 years old and have had a specific type of brain bleed that has been treated. They should also show signs of cerebral vasospasm through various tests. Participants will undergo procedures related to spinal cord stimulation and will need to attend follow-up visits to monitor their progress. It's important for potential participants to be in good overall health and not have certain conditions that could complicate their participation, such as ongoing bleeding issues or severe heart problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Untreated ruptured aneurysm
• • Cerebral infarction in the territory of the spastic arteries or massive disseminated infarction
• • Signs of cerebral herniation
• • Uncontrollable intracranial pressure
• • Infection
• • Coagulation disorder
• • Is participating in another interventional trial
• • Circulatory instability
• • Severe congestive heart failure
• • Patients with an elevated risk of bleeding
• • Known allergy to implanted materials (Silicon, Titanium)