Cervical spinal cord stimulation for treating cerebral vasospasm after subarachnoid hemorrhage

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

This study is testing if spinal cord stimulation can help people who have had a brain bleed by reducing blood vessel tightening in the brain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 1 site (Bern)
• Trial ID: NCT05150002 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of cervical spinal cord stimulation (SCS) on cerebral vasospasm following aneurysmal subarachnoid hemorrhage (SAH). It aims to understand the mechanisms by which SCS may alleviate vasoconstriction of cerebral arteries, potentially improving cerebral blood flow and reducing the risk of ischemia and infarction. Participants will be enrolled based on specific criteria related to their condition and will undergo spinal cord stimulation as an intervention. The study seeks to provide insights into a novel therapeutic approach for a serious complication of SAH.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with Fisher 3 grade subarachnoid hemorrhage and confirmed cerebral vasospasm.

Not a fit: Patients with conditions preventing spinal cord stimulation lead implantation or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce morbidity and mortality associated with cerebral vasospasm after subarachnoid hemorrhage.

How similar studies have performed: While spinal cord stimulation has shown promising results in animal studies, this approach in the context of cerebral vasospasm after SAH is novel and has not been extensively tested in humans.

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)

Where this trial is running

Bern

• Dep. of Neurosurgery, Bern University Hospital — Bern, Switzerland (Recruiting)

Study contacts

• Principal investigator: Janine Ai Schlaeppi, MD — Department of Neurosurgery, Inselspital
• Study coordinator: Janine A Schlaeppi, MD

Conditions Cerebral Vasospasm; Subarachnoid Hemorrhage