TerminatedNot Applicable

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

Stopped: Sponsor left

Switzerland1 participantsStarted 2023-06-30

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of baseline flow velocity

Timeframe: 14 days after onset vasospasm

Trial details

NCT IDNCT05150002

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-12

View on ClinicalTrials.gov More Cerebral Vasospasm trials