Paradoxical Lucidity for Dementia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore moments of sudden clarity, known as paradoxical lucidity, in individuals with severe dementia. Researchers seek to understand these brief episodes through real-time brain monitoring (real-time video EEG monitoring) and symptom diaries. The study targets those with advanced dementia who are in hospice care and have ceased receiving nutrition or fluids. The trial aims to define and measure these episodes to better understand their causes and significance. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance understanding and care for individuals with advanced dementia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that real-time video EEG monitoring and symptom diaries are safe for use in this study?
Earlier studies have shown that real-time video EEG monitoring (a method to track brain activity) is safe in various settings. Participants generally tolerate it well, with no major side effects reported. Some may experience minor discomfort from the electrodes on their scalp.
Research has shown that symptom diaries (daily journals to track experiences) are safe for patients. They have been used in many studies without causing harm. Keeping a diary is straightforward and doesn't involve any medical procedures, making it a low-risk option for participants.
Both methods—video EEG monitoring and symptom diaries—are considered safe based on previous research and their non-invasive nature.
Why are researchers excited about this trial?
Researchers are excited about the trial investigating paradoxical lucidity in severe end-stage dementia because it explores a novel approach to understanding this condition. Unlike standard treatments that primarily focus on managing symptoms with medications, this trial uses real-time video EEG monitoring and symptom diaries to capture moments of unexpected clarity in patients. This approach could reveal new insights into the brain's functioning during dementia's final stages, potentially opening up avenues for new treatments or interventions. By documenting these lucid episodes, the trial aims to better understand their occurrence and underlying mechanisms, which could ultimately improve the quality of life for individuals with severe dementia.
What evidence suggests that real-time video EEG monitoring and symptom diaries are effective for studying paradoxical lucidity in advanced dementia?
Research has shown that episodes of paradoxical lucidity (PL) in people with severe dementia suggest the condition might not be completely irreversible. PL refers to unexpected moments when individuals with advanced dementia suddenly become clear and aware. Although solid data on why this happens is limited, some studies have found that these moments can last from a few minutes to several hours. Tools like real-time video EEG monitoring and symptom diaries do not prove PL itself, but they help capture and understand these episodes better as they happen. These methods aim to identify possible brain activity patterns during PL, which might help explain why it occurs and explore new treatment options.
Who Is on the Research Team?
Sam Parnia, MD, PhD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I
Data collection through online surveys and focus groups, assessing safety and feasibility of symptom diaries and real-time video EEG monitoring
Phase II
Expansion of study population, refinement of study methods, and creation of a definition and measurement scale for paradoxical lucidity
Follow-up
Participants are monitored for safety and effectiveness after study phases
What Are the Treatments Tested in This Trial?
Interventions
- Real-time Video EEG Monitoring
- Symptom Diaries
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
National Institute on Aging (NIA)
Collaborator