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NCT Number: NCT06763471

Measuring Single Neuron Activity in the Brain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The SUNAN study plans to recruit fifty patients scheduled for brain surgery, such as for tumour removal or operations that involve the fluid (cerebrospinal fluid) within the brain, at the National Hospital for Neurology and Neurosurgery. Participation is voluntary, and the suitability will be assessed by the participant's neurosurgeon.

Patients who participate in SUNAN will undergo their planned neurosurgery as per standard of care with the additional step of a neurophysiological recording made from the brain using a Neuropixels probe. This recording step and the data collected will not affect the rest of the patients care which will proceed in the usual way and the data is collected solely for scientific purposes.

The investigators believe that the insights gained from these electrical recordings from individual neurons will deepen our understanding of brain function and potentially lead to improved diagnosis and treatment of neurological diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Aged 18 years and over.
  • Documented informed consent to participate.
  • Undergoing a transcranial neurosurgical procedure at the National Hospital for Neurology and Neurosurgery (NHNN) in which part of the cerebral cortex 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.
  • 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

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Single units isolated

    Time frame: Timepoint - At time of planned neurosurgery.

    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.

Secondary outcomes

  1. Experience of using large scale single-unit recording

    Time frame: Through study completion, an average of 1 year

    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.

  2. Iterations made to the surgical and electrophysiological technique

    Time frame: Through study completion, an average of 1 year

    Reporting on iterations made to the surgical and electrophysiological technique over the course of the study.

  3. Potential refinements in technique

    Time frame: Through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Francis Crick Institute

Registry information

Official study title

Single Unit Neurophysiological Architecture of the Neocortex (SUNAN)

Acronym: SUNAN

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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