Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID06409806

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

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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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 16 or older undergoing intracranial surgery where fixed brain retraction is anticipated
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-operative Follow-up

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

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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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