Measuring Single Neuron Activity in the Brain

NCT06763471 | Not Yet Recruiting DMC

• 1 other identifier: 159671
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neurological Diseases or Conditions

Keywords

Neuron activity; Single unit; Neurosurgery; Neuropixels; Neurophysiology; Cortical

Outcome Measures

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.

  Timepoint - At time of planned neurosurgery.

Secondary Outcomes (3)

• Experience of using large scale single-unit recording

  Through study completion, an average of 1 year

• Iterations made to the surgical and electrophysiological technique

  Through study completion, an average of 1 year

• Potential refinements in technique

  Through study completion, an average of 1 year

Study Arms (1)

Neuropixels recording

EXPERIMENTAL

Participants undergoing planned neurosurgery that undergo a maximum of 15 minutes neurophysiological recording using Neuropixels

Device: Neuropixels recording intraoperatively during planned neurosurgery

Interventions

Neuropixels recording intraoperatively during planned neurosurgery DEVICE

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 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.

Neuropixels recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• Participants unable to understand English sufficiently well to read the patient facing documents and consent in English.
• Participants not undergoing their treatment through National Health Service (NHS) care (i.e. private patients are excluded).

Sponsors & Collaborators

• University College, London: lead
• Francis Crick Institute: collaborator

Central Study Contacts

William Muirhead

CONTACT

+44 (0) 20 7679 2000; will.muirhead@nhs.net

Grace Auld

CONTACT

+44 (0) 20 7679 2000; g.auld@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 8, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 8, 2025

Record last verified: 2024-12