Paradoxical Lucidity in Severe End-Stage Dementia

Recruiting

• Conditions: Dementia

• Registration Number: NCT05234866
• Lead Sponsor: NYU Langone Health

Brief Summary

Cognitive decline in dementia is considered irreversible, however episodes of paradoxical lucidity (PL) in severe dementia suggest other mechanisms may be in play. Beyond anecdotal reports of transient PL events occurring in patients predominantly in late-stage dementia and typically lasting anywhere from a few minutes to several hours, little is known about PL. The study team proposes to develop and conduct a mixed methods prospective study of PL during end stage advanced dementia, creating a definition and measurement scale for PL in advanced dementia, and identifying the potential electro cortical biomarkers of PL in advanced dementia. This study will be divided in two phases: Phase I and Phase II. During Phase I, the study team will collect sufficient and necessary data through an online survey and focus groups as well as assess the safety and feasibility of using symptom diaries (also known as daily trackers or journals) and real-time video EEG monitoring (vEEG). After preliminary review of the study procedures, the PI will decide whether to move onto the Phase II. The second phase will aim to expand the study population and refine study methods as well as create a definition and measurement scale for PL in advances dementia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-06-02
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• Age > 18 years
• Advanced (severe) dementia diagnosed using the Global Deterioration Scale (GDS) with a score of 7 or the Palliative Performance Scale (PPS) with a score of less than 30%
• Accepted for hospice care based on the Medicare eligibility guidelines
• No longer being provided with nutrition or fluids
• Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period

Exclusion Criteria

• Cognitive or functional impairment due to a diagnosis other than dementia
• Dementia with a GDS score <7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I - Number of families who express interest in the study and contact the research team	up to Day 7
Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.	up to Day 7
Phase I - Number of diary reports completed and returned to research staff	up to Day 7
Phase I - Total number of instances in which video EEG monitoring was successfully initiated	up to Day 7
Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days	up to Day 7
Phase I and II - Number of self-reports of patient distress/discomfort in relation to symptom diary use and recording of potential episodes of paradoxical lucidity (PL) using mobile devices	up to Day 7
Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies	up to Day 7
Phase I - Time taken to establish video EEG monitoring in homes or nursing homes	up to Day 7
Phase I - Average number of days for which video EEG monitoring was completed	up to Day 7

Secondary Outcome Measures

Name	Time	Method
Phase II - Average number of changes in EEG rhythm during PL	Baseline, up to Day 7
Phase II - Change in average number of changes in EEG rhythm	Baseline, up to Day 7

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States