Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409806
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-01
Brief Title:
Electrocorticographic Monitoring of Brain Retraction Injury EMBRI
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Electrocorticography As a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction an IDEAL Stage 1 Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Currently awaiting extension
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBRI
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None