Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used.
Disqualifiers
Patients without capacity to give consent at time of recruitment
Trial design
Design model
Single group
Treatments tested in this trial
ECOG Array
Other interventionThe 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Intervention armExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Over a 28 month period from November 2022 to March 2026Secondary outcomes
1
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.
Time frame
Over a 28 month period from November 2022 to March 2026Sponsors and contacts
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Source ClinicalTrials.gov