Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Evaluation of the Efficacy of Transcutaneous Trigeminal Nerve Stimulation for Prevention of Cerebral Vasospasm and Its Consequences After Subarachnoid Haemorrhage Due to Ruptured
Brief Summary:
Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly related to the initial damage induced by SAH and delayed cerebral ischaemia (DCI), which is generally secondary to cerebral vasospasm.
Cerebral vasospasm is one of the main factors of poor prognosis after SAH, as it is associated with a 1.5- to 3-fold increase in the mortality rate during the 2 weeks following SAH in these patients.
Despite a significant improvement in the time to management of this disease and the fact that the ruptured aneurysm is very often rapidly excluded by surgical or endovascular intervention, patients who survive the initial SAH remain at risk of severe complications over the following 2 weeks.
Vascular stenosis of an arterial segment, called cerebral vasospasm, is observed in more than 70 to 95% of cases on digital subtraction angiography between the 7th and 14th days after ruptured aneurysm. This angiographic vasospasm can be responsible for cerebral infarction in 52 to 81% of cases.
Despite 50 years of research, no clearly demonstrated effective treatment for vasospasm is currently available.
This is a multicentre, randomized, comparative study, including 364 patients during the acute phase following ruptured aneurysm, in whom management is very often limited to control of complications, after exclusion of the aneurysm.
The objective of this study is to validate the efficacy of transcutaneous trigeminal nerve stimulation for the prevention