Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

NCT ID: NCT06409806

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Injury Neurosurgery Brain Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention arm

Group Type EXPERIMENTAL

ECOG Array

Intervention Type 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.

Interventions

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ECOG Array

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Hospital Neurology and Neurosurgery

London, Greater London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Siddharth Sinha

Role: CONTACT

004420 3456 7890

Facility Contacts

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Siddharth Sinha

Role: primary

Other Identifiers

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310742

Identifier Type: -

Identifier Source: org_study_id

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