An observational study in Lewy Body Disease, Lewy Body Dementia and Parkinson Disease, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by NYU Langone Health · Observational
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.
Visual hallucinations are highly prevalent in Lewy Body Diseases (LBD), a prominent group of neurodegenerative disorders that includes Dementia with Lewy Bodies, Parkinson's disease, and Parkinson's disease dementia. Currently, scientists do not fully understand how the brain creates these false visual images. This lack of knowledge makes it difficult to develop effective treatments.
This study aims to understand the neural mechanisms that give rise to these hallucinatory experiences. The study will include three groups of volunteers:
During the study, participants will undergo safe, non-invasive brain imaging scans. While being scanned, they will either rest or complete visual computer tasks.
The results of this study will help map the brain networks responsible for visual hallucinations. These insights will help researchers develop better, targeted interventions for this disabling symptom.
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.
I) LBD Patients with or without visual hallucinations
II) Age-matched controls (healthy volunteers)
Exclusion Criteria:
I) LBD Patients with or without visual hallucinations
II) Age-matched controls (healthy volunteers)
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.
Behavioral: Behavioral Tasks · Other: MRI/MEG Scans
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.
Behavioral: Behavioral Tasks · Other: MRI/MEG Scans
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.
Behavioral: Behavioral Tasks · Other: MRI/MEG Scans
Delivered as part of outpatient experimental sessions.
Delivered as part of outpatient experimental sessions.
Changes in recognition rate
Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.
Time frame: 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.
Time frame: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
Plan to share: Yes — 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.
No publications or documents are linked to this record.
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