Subarachnoid Haemorrhage (SAH) Clinical Trial
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 Aneurysm: a Multicentre, Randomized, Double-blind Study
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 of vasospasm and limitation of the consequences of delayed
cerebral ischaemia after SAH.
This is an innovative project, as it comprises intervention in these patients prior to the
development of complications and could limit the development of these complications. The
prevention tool, based on external facial nerve stimulation, is a totally innovative,
reversible and noninvasive technique. Use of nerve stimulation in this indication has never
been previously reported and could radically modify the intensive care management of this
disease over the years to come.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02946437 -
Sevoflurane in Subarachnoidal Haemorrhage
|
Phase 2 |