Visual Hallucinations in Lewy Body Diseases
Understanding Neural Mechanisms Underlying Visual Hallucinations in Lewy Body Diseases
2 other identifiers
observational
234
1 country
1
Brief Summary
The goal of this basic experimental study involving humans (BESH) protocol is to improve the understanding of neural mechanisms underlying visual hallucinations in Lewy Body diseases to inform future treatment developments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2026
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2026
CompletedFirst Submitted
Initial submission to the registry
September 16, 2026
CompletedFirst Posted
Study publicly available on registry
September 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2031
September 30, 2026
September 1, 2026
5 years
September 16, 2026
September 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in recognition rate
Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.
Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
Euclidean distance in neural activity patterns
Neural response patterns assessed by Euclidean distance in neural activity pattern between pre- and post-disambiguation stages.
Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
Study Arms (3)
Patients with Lewy Body Diseases who experience visual hallucinations
Patients will complete between one and multiple outpatient experimental sessions, depending on the specific scientific question being addressed, the type of data required by the investigator and the patient's availability. Potential interventions include: behavioral tasks, MRI scans, MEG scans.
Patients with Lewy Body Diseases who do not experience visual hallucinations
Patients will complete between one and multiple outpatient experimental sessions, depending on the specific scientific question being addressed, the type of data required by the investigator and the patient's availability. Potential interventions include: behavioral tasks, MRI scans, MEG scans.
Age-matched controls
Patients will complete between one and multiple outpatient experimental sessions, depending on the specific scientific question being addressed, the type of data required by the investigator and the patient's availability. Potential interventions include: behavioral tasks, MRI scans, MEG scans.
Interventions
Delivered as part of outpatient experimental sessions.
Delivered as part of outpatient experimental sessions.
Eligibility Criteria
Three subject cohorts will be recruited for this study: 1) LBD patients who experience visual hallucinations (LBD-VH group); 2) patients diagnosed with LBD without any visual hallucinations (LBD-non-VH group, control arm); 3) age and demographically matched controls.
You may qualify if:
- I) LBD Patients with or without visual hallucinations
- yrs
- Fluent in English or Spanish
- Score at least 24 out of 30 on the MoCA
- Diagnosed with Lewy Body diseases, including Parkinson's disease and Lewy Body dementias (Parkinson's disease dementia and dementia with Lewy bodies)
- II) Age-matched controls (healthy volunteers)
- yrs
- Fluent in English or Spanish
- Score at least 26 out of 30 on the MoCA
You may not qualify if:
- I) LBD Patients with or without visual hallucinations
- History of traumatic brain injury or significant head trauma
- History of significant neurologic disorders other than Lewy body diseases
- Meets DSM-IV criteria for substance abuse or dependence
- For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form
- II) Age-matched controls (healthy volunteers)
- History of traumatic brain injury or significant head trauma
- History of significant neurologic disorders other than Lewy body diseases
- Meets DSM-IV criteria for substance abuse or dependence
- For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Biyu He, 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
September 16, 2026
First Posted
September 30, 2026
Study Start
September 15, 2026
Primary Completion (Estimated)
August 31, 2031
Study Completion (Estimated)
August 31, 2031
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will become available by the time of publication or, the end of the period of performance, including any no-cost extension. Data will remain available for at least as long as required by the applicable repository and/or journal policies.
- Access Criteria
- The investigator who proposes to use the data will be granted access upon reasonable request. De-identified behavioral and fMRI data underlying peer-reviewed publications will be shared through established repositories, such as OpenNeuro, GitHub, and figshare. Data will be shared by the time of publication or, for other findings, by the end of the award's period of performance, and will remain available for at least as long as required by the applicable repository and/or journal policies. Repository links will be provided when available
The de-identified participant data from the final research dataset will be shared upon reasonable request by the time of publication or, the end of the period of performance, including any no-cost extension. Data will remain available for at least as long as required by the applicable repository and/or journal policies. De-identified behavioral and fMRI data underlying peer-reviewed publications will be shared through established repositories, such as OpenNeuro, GitHub, and figshare. Data will be shared by the time of publication or, for other findings, by the end of the award's period of performance, and will remain available for at least as long as required by the applicable repository and/or journal policies. Repository links will be provided when available. All potentially identifying information will be fully removed prior to releasing the data.