Actively Recruiting
Electrocorticography As a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction: an IDEAL Stage 1 Study
Led by University College, London · Updated on 2024-09-19
6
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human feasibility study to explore new electrophysiological recording methods during neurosurgery in adults. This study builds on earlier experiments in mice and aims to monitor brain retraction injury during planned intracranial surgeries. It focuses on using electrocorticography (ECoG) as a neurophysiological marker to detect potential brain injury caused by surgical retraction. Participants will undergo their scheduled neurosurgical procedures as usual, with standard neuro-monitoring techniques such as EEG, motor evoked potentials (MEP), and somatosensory evoked potentials (SSEP) applied if indicated. Additionally, an ECoG electrode array will be placed under the brain retractor by the surgeon during the operation. Other electrode arrays may be positioned on unretracted brain areas to serve as references. During the study, researchers will evaluate how well the ECoG brain retractor integrates into the usual neurosurgical workflow over a 28-month period from November 2022 to March 2026. They will analyze the electrophysiological data collected to explore correlations between ECoG signals and the duration of brain retraction. Participants will receive standard care alongside study monitoring, with no changes to their usual surgical treatment.
CONDITIONS
Brief Title
Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 or older undergoing intracranial surgery where fixed brain retraction is anticipated
You will not qualify if you...
- Patients who do not have the capacity to give consent at the time of recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgical procedure
Participants undergo their planned intracranial neurosurgical procedure with standard brain retractors and neuromonitoring; additionally, an electrocorticography (ECoG) array is positioned under the retractor during surgery to monitor brain activity.
1 surgical visit (in-person)
Duration - Up to 28 months from surgery
Participants are monitored post-surgery to evaluate integration of the ECoG brain retractor and to analyze electrophysiological data related to brain retraction duration.
Follow-up visits as per standard clinical care
Trial Site Locations
Total: 1 location
1
National Hospital Neurology and Neurosurgery
London, Greater London, United Kingdom, WC1N 3BG
Actively Recruiting
Research Team
S
Siddharth Sinha
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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