Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change of baseline flow velocity
研究概览
简要总结
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.
详细描述
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%. The exact pathophysiological mechanisms underlying cerebral vasospasm are still not known in detail.
A wide range of different therapeutic options with various efficacies are available, triple-H therapy and endovascular treatment options like intra-arterial application of vasodilators e.g. Nimodipine or Papaverine or transluminal balloon angioplasty have been reported and are applied to prevent and treat cerebral vasospasm after SAH. Calcium channel blockers such as nimodipine or nicardipine improve outcome in patients after SAH and reduce the risk of secondary ischemia. The benefit of the different therapies is undoubted, but there is still potential for improvement concerning the rate of morbidity and mortality.
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.
Subjects are enrolled into the study, if radiographical vasospasms are detected in CTA, CTP, cerebral angiography or TCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change of baseline flow velocity
时间窗: 14 days after onset vasospasm
The change of baseline flow velocity from the onset of vasospasm to day 14 assessed with Doppler ultrasound showing the effect of cervical SCS.
次要结局
- Headache(Day 7- 14)
- Vasospasm changes in angiography and perfusion in CTP(14 days after stimulation)
- Triple-H therapy(14 days after stimulation)
- Vasospasm changes in CTA and perfusion in CTP(14 days after stimulation)
- Angioplasty or intra-arterial application of vasodilators(14 days after stimulation)
- Consumption of analgesics(Day 7- 14)
- Intracerebral pressure (ICP)(Day 7- 14)
- Side effects of SCS(Day 7- 14)
- Vasospasm changes in angiography and perfusion in CTP(48 hours after stimulation)
- Vasospasm changes in CTA and perfusion in CTP(48 hours after stimulation)
- Vasospasm changes in angiography and perfusion in CTP(96 hours after stimulation)
- Vasospasm changes in CTA and perfusion in CTP(96 hours after stimulation)