Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-28 @ 12:30 AM
Study NCT ID:
NCT05091632
Status:
SUSPENDED
Last Update Posted:
2025-10-27
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Verbal Comprehension and Cognitive Processes in Patients Admitted to the Palliative and Supportive Care Unit
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Can You Hear Me? Assessment of Verbal Comprehension and Cognitive Processes in Patients in the Last Days of Life
Status:
SUSPENDED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates the use electroencephalography (EEG - a test that measures brain waves) to learn if patients who appear unresponsive (do not respond to noises, words, or touch) retain any consciousness. Families want to know if their loved ones who are unresponsive can still hear them or feel any discomfort. Information gained from this study may have important impact in how patients, caregivers, and doctors make decisions.
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the magnitude of electroencephalography (EEG) response to verbal stimuli among cancer patients in the last days in life admitted to a palliative and supportive care unit (PSCU).
II. To examine the feasibility of conducting EEG in cancer patients in the last days of life.
SECONDARY OBJECTIVES:
I. To compare the magnitude of EEG response between impending death cohort and control cohort.
II. To determine the association between the magnitude of EEG response and clinical assessments (e.g. JFK Coma Recovery Scale-Revised \[CRS-R\], Glasgow Coma Scale \[GCS\], Richmond Agitation Sedation Scale \[RASS\], Memorial Delirium Assessment Scale \[MDAS\]) in impending death cohort and control cohort separately.
III. To determine the magnitude of EEG response to pressure/noxious stimuli in impending death cohort and control cohort separately.
IV. To examine serial EEG changes in auditory cortex activation and cognitive processing in cancer patients over the last days of life.
OUTLINE:
Patients undergo EEG over 30 minutes daily until death or discharge and complete questionnaires over 30 minutes daily until death or discharge to check level of consciousness, thought, and ability to communicate.
I. To estimate the magnitude of electroencephalography (EEG) response to verbal stimuli among cancer patients in the last days in life admitted to a palliative and supportive care unit (PSCU).
II. To examine the feasibility of conducting EEG in cancer patients in the last days of life.
SECONDARY OBJECTIVES:
I. To compare the magnitude of EEG response between impending death cohort and control cohort.
II. To determine the association between the magnitude of EEG response and clinical assessments (e.g. JFK Coma Recovery Scale-Revised \[CRS-R\], Glasgow Coma Scale \[GCS\], Richmond Agitation Sedation Scale \[RASS\], Memorial Delirium Assessment Scale \[MDAS\]) in impending death cohort and control cohort separately.
III. To determine the magnitude of EEG response to pressure/noxious stimuli in impending death cohort and control cohort separately.
IV. To examine serial EEG changes in auditory cortex activation and cognitive processing in cancer patients over the last days of life.
OUTLINE:
Patients undergo EEG over 30 minutes daily until death or discharge and complete questionnaires over 30 minutes daily until death or discharge to check level of consciousness, thought, and ability to communicate.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: