A Randomised Control Trial of SEEG Electrode Placement methods
Research type
Research Study
Full title
Single-blinded Randomised Case Control Parallel Group Single-site Investigation of Stereoencephalography Electrode Placement in Patients with Refractory Focal Epilepsy.
IRAS ID
206408
Contact name
John Duncan
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Research Summary
It is estimated that 1% of the population suffer from Epilepsy. Between 30-40% of these patient do not achieve adequate seizure control despite a trial of two or more anti-epileptic drugs. Seizures have long term psychosocial impacts on patients. Surgical treatment may offer a potential cure for these patients. To determine whether surgery is possible a specialist evaluation of the patient is required including detailed clinical neurophysiological, neuropsychological and multi-modal imaging. In cases where the evaluation confirms a defined surgical target as the cause surgery can be performed.In almost half of cases further investigation is required in the form of electrical recordings from the surface of the brain (subdural grids) or electrodes implanted deep within the brain (depth electrodes). Recordings during seizures using these techniques help to more accurately define the region for surgery. Depth electrodes carry a number of risks including bleeding, infection and neurological deficit due to damage to the brain as a result of misplacement. Electrode trajectories have to be carefully planned to avoid blood vessels and important brain structures.
Currently neuro-navigation systems are used in combination with a mechanical arm to manually align and insert the electrode along a predefined trajectory. Using a novel robotic system (iSYS robot-assisted system, Medizintechnik GmbH) we aim to undertake a randomized controlled trial to compare the surgical duration and accuracy of robot-assisted electrode implantation in 16 patients with the currently used mechanical arm based technique in 16 patients. In addition, we also aim to determine if haemorrhage rate, infection rate, neurological deficit, proportion of patients that go on to surgical treatment, seizure freedom rate and surgeon convenience are significantly affected.
Summary of Results
This study shows that the iSYS1 robotic trajectory device reduces Stereotactic EEG (SEEG) electrode implantation time compared to the standard technique. The overall reduction in total operative time, included setting up, positioning, navigation and closure was modest and not significantly different. For SEEG, the iSYS1 robotic guidance system offers a consistent and effective solution comparable to the standard technique conventionally employed at our institution.Further research should focus on cost–benefit analyses of introducing robotic devices into clinical services and prospective head-to-head comparisons between different robotic devices in these and other indications such as Deep Brain Stimulation (DBS).
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0016
Date of REC Opinion
20 Feb 2017
REC opinion
Further Information Favourable Opinion