Measuring Single Neuron Activity in the Brain
ConditionNeurological Diseases or Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
The SUNAN (Single Unit Neurophysiological Architecture of the Neocortex) study aims to understand how individual brain cells called neurons interact and communicate, and how the neurons can be affected in neurological disease. Using an advanced digital probe called the "Neuropixels probe," which is as thin as a human hair, the investigators can record electrical activity from individual neurons on the outmost layer of the brain (cerebral cortex). This electrical (neurophysiological) activity recording technique allows the investigators to isolate and monitor single-neuron activity from the human brain during planned neurosurgical operations in real time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years and over.
Documented informed consent to participate.
Resected e.g., as removal of part of a tumour or epilepsy focused. Or
Transgressed as part of the surgical approach to reach a deeper target e.g., resection of a deep tumour or cavernoma.
Disqualifiers
Participants who lack the capacity to give informed consent.
Participants who are pregnant or breast feeding at the time of surgery.
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.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Neuropixels recording intraoperatively during planned neurosurgery
DeviceThe 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 procedure on the brain. As part of the surgery, a region of cerebral cortex on the convexity of the brain will be: * Resected e.g., as removal of part of a tumour or epilepsy focused. Or * Transgressed as part of the surgical approach to reach a deeper target e.g., resection of a deep tumour or cavernoma. Or • Transgressed by the passage of a surgical implant e.g., a ventriculoperitoneal shunt catheter or deep brain stimulation electrode. Within this region of the brain that is going to be resected or transgressed, the research team will undertake a single-unit resolution neurophysiological recording (NR) using a digital neural probe (Neuropixels) for a maximum of 15 minutes.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Neuropixels recordingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Single units isolated
Outcome name - Descriptive reporting on the number of well isolated single neuronal units observed during neurophysiological recording of the brain during planned neurosurgery. Metric/method of measurement - Neurophysiological activity of the brain will be described through analysis of electrical activity recorded. The detection of spikes represents 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.
Time frame
Timepoint - At time of planned neurosurgery.Secondary outcomes
1
Experience of using large scale single-unit recording
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 set-up. Reporting on the experience of using large scale single-unit recording techniques in humans undergoing neurosurgery.
Time frame
Through study completion, an average of 1 year2
Iterations made to the surgical and electrophysiological technique
Reporting on iterations made to the surgical and electrophysiological technique over the course of the study.
Time frame
Through study completion, an average of 1 year3
Potential refinements in technique
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 theatre.
Time frame
Through study completion, an average of 1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
Francis Crick Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: