Patients undergoing planned cranial neurosurgery Surgery
Conditions
Interventions
The SUNAN study is a basic science study involving a procedure to record single-unit neurophysiological activity with human participants who are already undergoing a transcranial neurosurgical procedu
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. Able to give their own consent and written informed consent to participate 3. Undergoing a transcranial neurosurgical procedure at the National Hospital for Neurology and Neurosurgery in which part of the cerebral cortex will be: 3.1. Resected e.g., as removal of part of a tumour or epilepsy focused Or 3.2. Transgressed as part of the surgical approach to reach a deeper target e.g., resection of a deep tumour or cavernoma Or 3.3. Transgressed by the passage of a surgical implant e.g., a ventriculoperitoneal shunt catheter or deep brain stimulation electrode 4. Surgery felt to be technically suitable for the neurophysiological recording technique by the Chief Investigator and responsible Consultant Neurosurgeon. For example, participants having surgery in an unusual position may present problems for the neurophysiological recording step.
Exclusion criteria
Exclusion criteria: 1. Participants who lack the capacity to give informed consent. 2. Participants who are pregnant or breastfeeding at the time of surgery. 3. Participants deemed to be unsuitable for recruitment to the study by the responsible Consultant Neurosurgeon. If in the view of the treating consultant involvement in the study would compromise the patient’s surgery or present an unacceptable risk to them, they will not be recruited to the study. For example, if the participant does not meet the standard of care preoperative checks. 4. Concern from the Consultant Neurosurgeon or treating Anaesthetist that there would be an unreasonable burden on the patient to participate in the study. For example, risk due to increased length of anaesthetic time. 5. For participants requiring anaesthesia for their pre-planned brain surgery, an American Society of Anaesthesiologists (ASA) physical status classification system score of 4 and higher. 6. Participants unable to understand English sufficiently well to read the patient-facing documents and consent in English. 7. Participants not undergoing their treatment through NHS care (i.e. private patients are excluded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive reporting on the number of well-isolated single neuronal units observed during the neurophysiological recording of the brain during planned neurosurgery. The neurophysiological activity of the brain will be described through an analysis of the electrical activity recorded. The detection of spikes represents the depolarisation of single neuronal units (“single units”). Well-isolated single-units will be defined by clustering metrics, interval spike interval violations and/or other neurophysiological analysis. Descriptive reporting will include the number of individual units recorded, their spiking rates and correlation. Timepoint – At time of planned neurosurgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be reported for each participant to gather information on the recording technique. For example, a description of the recording setting may include the arrangement of ground and reference electrodes as well as the operative setup. At a minimum of 6-month intervals throughout the study, the secondary outcomes will be reviewed and discussed by the research team. The following secondary outcome measures will be assessed through study completion, an average of 1 year: 1. Reporting on the experience of using large-scale single-unit recording techniques in humans undergoing neurosurgery 2. Reporting on iterations made to the surgical and electrophysiological technique 3. Reporting on potential refinements that could be made to the described technique which could enable better quality data and that could be of benefit to other researchers conducting similar work. For example, equipment set-up/noise restrictions in the theatre | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel McComish
Outcome results
None listed