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NCT Number: NCT06409806

Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments.

Participants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital Neurology and Neurosurgery

London, Greater London, WC1N 3BG, United Kingdom

Location status: Recruiting

Location contact

Siddharth Sinha

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used.

Exclusion criteria

  • Patients without capacity to give consent at time of recruitment

Treatment and study plan

ECOG Array

Other

The patient will undergo their intracranial neurosurgical procedure as planned, using conventional brain retractors and neurosurgical equipment.

Standard neuromonitoring (EEG, MEP, SSEP) will be placed after the induction of neuroanaesthesia if indicated. Additional to whatever conventional EMBRI neuromonitoring is used, intraoperatively an ECoG array will be positioned under the retractor by the operating surgeon. Further electrode arrays may be placed on the cortical surface remote from the retractor as needed to establish a reference.

Typically we anticipate one ECoG array under the retractor blade with a reference array on an area of unretracted brain.

Primary outcomes

  1. Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow.

    Time frame: Over a 28 month period from November 2022 to March 2026

    The primary outcome is to report the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow based upon analysing prospective data including qualitative questionnaires administered to surgeons and scrub nurses, anonymised clinical data, and anonymised electrophysiological data.

    The primary outcome is to produce a descriptive report of the electrophysiological data recorded and the challenges encountered in the delivery of the novel electrophysiological recording for patients undergoing planned neurosurgical procedures at the National Hospital for Neurology and Neurosurgery, London.

Secondary outcomes

  1. Analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction.

    Time frame: Over a 28 month period from November 2022 to March 2026

    The secondary objective is to analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction. Post-operative clinical data, such as MRI brain scans, can be reviewed to investigate any ischemic events.

    We will perform an initial analysis of the electrophysiological data to see if neurophysiological stigmata of brain retraction injury can be identified, with the operation simultaneous recorded with the operative microscope.

Study contacts

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

Siddharth Sinha

CONTACT

[email protected]

004420 3456 7890

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

Electrocorticography As a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction: an IDEAL Stage 1 Study

Acronym: EMBRI

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
May 10, 2024
Registry last updated
Sep 19, 2024

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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