Neurological Diseases or ConditionsSUNANNCT06763471
Measuring Single Neuron Activity in the Brain
A study testing Neuropixels recording intraoperatively during planned neurosurgery in people with Neurological Diseases or Conditions, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Diseases or Conditions
- What is being tested?
- Neuropixels recording intraoperatively during planned neurosurgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single Unit Neurophysiological Architecture of the Neocortex (SUNAN)
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.
Read the detailed description
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.
- Conditions
- Neurological Diseases or Conditions
- Being tested
- Neuropixels recording intraoperatively during planned neurosurgery
- Keywords
- Neuron activity, Single unit, Neurosurgery, Neuropixels, Neurophysiology, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropixels recording intraoperatively during planned neurosurgeryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuropixels recording | Experimental | Participants undergoing planned neurosurgery that undergo a maximum of 15 minutes neurophysiological recording using Neuropixels Receives: Device: Neuropixels recording intraoperatively during planned neurosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Timepoint - At time of planned neurosurgery.
Secondary outcomes (3)
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.
Measured: Through study completion, an average of 1 year
Iterations made to the surgical and electrophysiological technique
Reporting on iterations made to the surgical and electrophysiological technique over the course of the study.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Diseases or ConditionsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Francis Crick Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763471
- Sponsor's protocol ID
- 159671
- Acronym
- SUNAN
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing plans for the current study are unknown and will be made available at a later date.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Unit Neurophysiological Architecture of the Neocortex (SUNAN)
- ClinicalTrials.gov ID
- NCT06763471
- Acronym / sponsor ID
- SUNAN / 159671
- Conditions
- Neurological Diseases or Conditions
- Keywords
- Neuron activity, Single unit, Neurosurgery, Neuropixels, Neurophysiology, Cortical
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Francis Crick Institute
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropixels recording | Experimental | Device: Neuropixels recording intraoperatively during planned neurosurgeryParticipants undergoing planned neurosurgery that undergo a maximum of 15 minutes neurophysiological recording using Neuropixels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropixels recording intraoperatively during planned neurosurgeryThe 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. | Device | Neuropixels recording |
Primary outcome
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.
3 secondary outcomes
Experience of using large scale single-unit recording
Time frame: Through study completion, an average of 1 year
Iterations made to the surgical and electrophysiological technique
Time frame: Through study completion, an average of 1 year
Potential refinements in technique
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Undecided. The data sharing plans for the current study are unknown and will be made available at a later date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropixels recording intraoperatively during planned neurosurgery in people with Neurological Diseases or Conditions, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Muirhead (+44 (0) 20 7679 2000, will.muirhead@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single units isolated (time frame: Timepoint - At time of planned neurosurgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.