Paradoxical Lucidity in Severe End-Stage Dementia

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia

• Study Type: Observational
• Enrollment (Estimated): 520

Contacts and Locations

• Study Contact: Name: Sam Parnia, MD, PhD; Phone Number: (646)-501-6923; Email: Sam.Parnia@nyulangone.org
• Study Contact Backup: Name: Natalia Leontovich; Phone Number: 917-227-0932; Email: pl@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: Sam Parnia, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Phase I (Feasibility Study)
Phase II (Prospective Study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sam Parnia, MD, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 20-01854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No