tVNS for aSAH

• Research type

  Research Study

• Full title

  Investigating the safety, tolerability and feasibility of transcutaneous vagus nerve stimulation following aneurysmal subarachnoid haemorrhage

• IRAS ID

  334282

• Contact name

  Ali Ali

• Contact email

  ali.ali@sheffield.ac.uk

• Sponsor organisation

  Sheffield Teaching Hospitals

• Clinicaltrials.gov Identifier

  NCT06374693

• Duration of Study in the UK

  2 years, 6 months, 3 days

• Research summary

  Subarachnoid haemorrhage (SAH) is a type of brain bleed, which can be
  complicated by issues including stroke which causes further brain injury in up to 30% of patients. Current treatments for SAH focus on improving blood supply but fail to address other important factors such as reducing inflammation. New treatments to improve outcomes following SAH are urgently needed.

  Stimulation of a nerve in the neck called the vagus nerve, which can be done
  through the skin (transcutaneous vagus nerve stimulation, tVNS) is known to relax
  blood vessels and reduce inflammation and is approved in other conditions such as
  epilepsy. In animals, vagus nerve stimulation improves survival after SAH, and is being studied in humans to reduce headaches after SAH.

  There is a theoretical role of tVNS in improving outcome after SAH. We aim to
  study whether tVNS is safe, tolerated, and feasible in SAH.

  We will recruit 30 patients admitted to Sheffield Teaching Hospitals with SAH to this study and will randomly allocate them to have either tVNS given 45 minutes, twice a day for 5 days, or sham stimulation (where we stimulate a different part of the ear). We will record how many treatments they successfully complete, how well tolerated the treatments are, and whether any side effects are experienced. We will also record what complications they suffer during their hospital stay, how long they stay in the hospital as well as their mood scores and functional ability scores on discharge from hospital. We will also take blood samples to look at levels of inflammation at the start and end of the treatment and we will trial using a special cap to measure the blood flow in the brain while have the treatment they are allocated.

  If tVNS is safe, well tolerated and feasible to perform after SAH we will plan a larger study.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  24/YH/0024

• Date of REC Opinion

  28 Feb 2024

• REC opinion

  Further Information Favourable Opinion