Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05234866

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Sam Parnia, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: up to Day 7

  2. Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.

    Time frame: up to Day 7

  3. Phase I - Number of families who express interest in the study and contact the research team

    Time frame: up to Day 7

  4. Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies

    Time frame: up to Day 7

  5. Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days

    Time frame: up to Day 7

  6. Phase I - Number of diary reports completed and returned to research staff

    Time frame: up to Day 7

  7. Phase I - Time taken to establish video EEG monitoring in homes or nursing homes

    Time frame: up to Day 7

  8. Phase I - Total number of instances in which video EEG monitoring was successfully initiated

    Time frame: up to Day 7

  9. Phase I - Average number of days for which video EEG monitoring was completed

    Time frame: up to Day 7

Secondary outcomes

  1. Phase II - Change in average number of changes in EEG rhythm

    Time frame: Baseline, up to Day 7

  2. Phase II - Average number of changes in EEG rhythm during PL

    Time frame: Baseline, up to Day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Leontovich

CONTACT

[email protected]

917-227-0932

Sam Parnia, MD, PhD

CONTACT

[email protected]

(646)-501-6923

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.