Robotic guidance of SEEG electrodes and brain biopsies

• Research type

  Research Study

• Full title

  Use of Autoguide and EpiNav for directing SEEG electrodes and cranial biopsies

• IRAS ID

  278563

• Contact name

  Andrew William McEvoy

• Contact email

  a.mcevoy@nhs.net

• Sponsor organisation

  UCL

• Clinicaltrials.gov Identifier

  Z6364106/2020/10/08, UCL data protection

• Duration of Study in the UK

  3 years, 0 months, 3 days

• Research summary

  A third of patients with Epilepsy are resistant to drug therapy. Neurosurgery can help finding the area responsible for the seizures. The removal of this area can cure seizures.
  To find the area responsible for the seizures, the Neurosurgeon needs to implant electrodes directly in the brain through small holes in the skull. This allow direct recording of the brain's electrical activity.
  This operation needs to be performed in a very precise manner to avoid complications such as bleeding and stroke.
  With this study we are aiming to use a robotic device to guide the implantation of electrodes in patients with Epilepsy.

  In patients with brain tumours, where the abnormality is not resectable or requires medical treatment only, it is of paramount importance to establish a diagnosis in order to direct treatment. These patients need a biopsy.
  This procedure is performed through a small hole in the skull and inserting a needle into a pre established target. The operation needs to be performed in a precise way to avoid missing the target or complications such as bleeding and stroke.

  We completed a randomised controlled trial in May 2019 using the first version of the robotic device. We successfully implanted, without any complication, more than 150 electrodes.

  With this study we will continue to use a newly CE marked version of the robot to align the trajectory both for the insertion of electrodes and the biopsies. We will aim to perform a total of 135 patients in 3 years.

  Patients will be invited to participate after a multidisciplinary meeting will ascertain the appropriateness for that specific neurosurgical procedure. Patients unable to give consent will not be included in the study.

  The primary outcome will be the time taken to perform the procedure, the accuracy of the alignment and histological diagnosis rate for the biopsies.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  21/PR/0078

• Date of REC Opinion

  31 Mar 2021

• REC opinion

  Further Information Favourable Opinion