Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568536
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Disorders of consciousness DoC caused by severe brain injury affect millions of people worldwide each year A patients level of consciousness in the intensive care unit ICU significantly impacts the recovery from disability and is a primary determinant of family decisions about withdrawal of life-sustaining therapy WLST However reliable assessment of consciousness in the ICU remains elusive Transcranial magnetic stimulation-electroencephalography TMS-EEG is a tool that has shown the best performance in detecting signs of consciousness in patients with chronic DoC The goals of this prospective observational study are to demonstrate the diagnostic performance and prognostic utility of TMS-EEG in the ICU setting
Detailed Description:
Disorders of consciousness DoC caused by severe brain injury affect millions of people worldwide each year A patients level of consciousness in the intensive care unit ICU significantly influences the recovery from disability and may affect family decisions about withdrawal of life-sustaining therapy WLST Transcranial magnetic stimulation-electroencephalography TMS-EEG has shown the best performance in detecting signs of consciousness in patients with chronic DoC The goals of this multi-center observational study are to demonstrate the diagnostic performance and prognostic utility of TMS-EEG in patients with DoC caused by severe brain injuries in the ICU
Through this research we aim to demonstrate that
TMS-EEG can detect 95 of conscious patients who are defined as conscious by a combination of tests that aim to detect overt and covert consciousness
TMS-EEG measurements can predict 6-month outcomes on the Disability Rating Scale DRS in patients in an acute vegetative state controlling for age Glasgow Coma Scale GCS score and injury mechanism
All participants will undergo repeated behavioral assessments task-based electroencephalography EEG and TMS-EEG Of note conventional brain magnetic resonance imaging MRI and task-based functional MRI are optional
Through this research we aim to demonstrate that
TMS-EEG can detect 95 of conscious patients who are defined as conscious by a combination of tests that aim to detect overt and covert consciousness
TMS-EEG measurements can predict 6-month outcomes on the Disability Rating Scale DRS in patients in an acute vegetative state controlling for age Glasgow Coma Scale GCS score and injury mechanism
All participants will undergo repeated behavioral assessments task-based electroencephalography EEG and TMS-EEG Of note conventional brain magnetic resonance imaging MRI and task-based functional MRI are optional
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None