Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

NCT06409806 | Recruiting

• 1 other identifier: 310742
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury; Neurosurgery; Brain Ischemia

Keywords

Brain retraction

Outcome Measures

Primary Outcomes (1)

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

  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.

  Over a 28 month period from November 2022 to March 2026

Secondary Outcomes (1)

• 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

Study Arms (1)

Intervention arm

EXPERIMENTAL

Other: ECOG Array

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients without capacity to give consent at time of recruitment

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

National Hospital Neurology and Neurosurgery

London, Greater London, WC1N 3BG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Brain Ischemia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Siddharth Sinha

CONTACT

004420 3456 7890; siddharth.sinha@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 10, 2024
• Study Start: August 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)