An interventional study of ECOG Array in Brain Injury, Neurosurgery and Brain Ischemia, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University College, London · Not applicable, Interventional, and Other
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.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 6 is below the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
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.
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 2026
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 2026
Plan to share: No
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