Subarachnoid Hemorrhage Clinical Trial
Official title:
Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study
NCT number | NCT05150002 |
Other study ID # | VasoStim |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 30, 2023 |
Est. completion date | September 2027 |
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | September 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Neurosurgery, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of baseline flow velocity | The change of baseline flow velocity from the onset of vasospasm to day 14 assessed with Doppler ultrasound showing the effect of cervical SCS. | 14 days after onset vasospasm | |
Secondary | Vasospasm changes in angiography and perfusion in CTP | Vasospasm changes in angiography and perfusion in CTP | 48 hours after stimulation | |
Secondary | Vasospasm changes in CTA and perfusion in CTP | Vasospasm changes in CTA and perfusion in CTP | 48 hours after stimulation | |
Secondary | Vasospasm changes in angiography and perfusion in CTP | Vasospasm changes in angiography and perfusion in CTP | 96 hours after stimulation | |
Secondary | Vasospasm changes in CTA and perfusion in CTP | Vasospasm changes in CTA and perfusion in CTP | 96 hours after stimulation | |
Secondary | Vasospasm changes in CTA and perfusion in CTP | Vasospasm changes in CTA and perfusion in CTP | 14 days after stimulation | |
Secondary | Vasospasm changes in angiography and perfusion in CTP | Vasospasm changes in angiography and perfusion in CTP | 14 days after stimulation | |
Secondary | Triple-H therapy | Development of symptomatic vasospasm from onset to day 14 with need for Triple-H therapy | 14 days after stimulation | |
Secondary | Angioplasty or intra-arterial application of vasodilators | Development of symptomatic vasospasm from onset to day 14 with need for angioplasty or intra-arterial application of vasodilators | 14 days after stimulation | |
Secondary | Intracerebral pressure (ICP) | Intracerebral pressure (ICP) | Day 7- 14 | |
Secondary | Headache | Headache measured by VAS Scale (Score 0-10 with 0 representing no pain, and 10 maximum pain intensity) | Day 7- 14 | |
Secondary | Consumption of analgesics | Consumption of analgesics | Day 7- 14 | |
Secondary | Side effects of SCS | Side effects of SCS | Day 7- 14 |
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