Brain Injury, Brain Ischemia, Neurosurgery
Conditions
Keywords
Brain retraction
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.
Interventions
OTHERECOG 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.
Sponsors
University College, London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow. | Over a 28 month period from November 2022 to March 2026 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United Kingdom
Contacts
Primary ContactSiddharth Sinha
Outcome results
None listed