Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

Not Applicable

Suspended

• Conditions: Brain Injury; Brain Ischemia; Neurosurgery
• Interventions: Other: ECOG Array

• Registration Number: NCT06409806
• Lead Sponsor: University College, London

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10
• Primary Completion: 2024-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	ECOG Array	-

Primary Outcome Measures

Name	Time	Method
Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow.	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 Outcome Measures

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

Trial Locations

Locations (1)

National Hospital Neurology and Neurosurgery; 🇬🇧 London, Greater London, United Kingdom