Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ECOG Array.
- Who it may be relevant to
- Registry conditions: Brain Injury, Neurosurgery, Brain Ischemia. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electrocorticography As a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction: an IDEAL Stage 1 Study
Overview
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.
Interventions
- 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 r
Primary outcome measures
- Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow. [Time frame: Over a 28 month period from November 2022 to March 2026]
Secondary outcome measures (1)
- Analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction. [Time frame: Over a 28 month period from November 2022 to March 2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- National Hospital Neurology and Neurosurgery — London
Identifiers
NCT: NCT06409806 · 310742