Paradoxical Lucidity in Severe End-Stage Dementia
1 other identifier
observational
520
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedStudy Start
First participant enrolled
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedAugust 14, 2025
August 1, 2025
3.8 years
January 31, 2022
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
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 self-reports of informants' distress or discomfort due to the presence of the video EEG device.
up to Day 7
Phase I - Number of families who express interest in the study and contact the research team
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 - 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 - Number of diary reports completed and returned to research staff
up to Day 7
Phase I - Time taken to establish video EEG monitoring in homes or nursing homes
up to Day 7
Phase I - Total number of instances in which video EEG monitoring was successfully initiated
up to Day 7
Phase I - Average number of days for which video EEG monitoring was completed
up to Day 7
Secondary Outcomes (2)
Phase II - Change in average number of changes in EEG rhythm
Baseline, up to Day 7
Phase II - Average number of changes in EEG rhythm during PL
Baseline, up to Day 7
Study Arms (2)
Phase I (Feasibility Study)
Phase II (Prospective Study)
Eligibility Criteria
1. Adults over 18 years of age diagnosed with advanced dementia 2. Hospice workers, geriatric, palliative care physicians and other healthcare providers 3. Family, friends and caregivers
You may qualify if:
- 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
You may not qualify if:
- Cognitive or functional impairment due to a diagnosis other than dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sam Parnia, MD, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2022
First Posted
February 10, 2022
Study Start
June 2, 2022
Primary Completion
March 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a date access agreement.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.