Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

Brain Injury Clinical Trial

— EMBRI  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06409806
• Other study ID #: 310742
• Status: Suspended
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 6
• Est. completion date: March 1, 2026
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Brain Ischemia
• Neurosurgery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	National Hospital Neurology and Neurosurgery	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction.	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.	Over a 28 month period from November 2022 to March 2026