Evaluation of Transcutaneous Trigeminal Nerve Stimulation for Prevention of Cerebral Vasospasm After Subarachnoid Haemorrhage
Condition: Subarachnoid Haemorrhage (SAH)
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Study type: Interventional

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 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.
    


Intervention name(s): Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention type(s): Device
Intervention description(s): All patients will undergo placement of a facial transcutaneous electrical nervous stimulation (TENS) device, but device activation will be randomized [active stimulation vs non-active (placebo) stimulation], for an initial period of 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention