Visual Hallucinations in Lewy Body Diseases

Understanding Neural Mechanisms Underlying Visual Hallucinations in Lewy Body Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Lewy Body Disease; Lewy Body Dementia; Visual Hallucinations; Parkinson Disease Dementia
• Intervention / Treatment: Behavioral: Behavioral Tasks; Other: MRI/MEG Scans

Detailed Description

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:

1. LBD patients who experience visual hallucinations
2. LBD patients who do not have visual hallucinations
3. age-matched volunteers without a significant neurological history

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.

• Study Type: Observational
• Enrollment (Estimated): 234

Contacts and Locations

• Study Contact: Name: Nalini Jeet; Phone Number: 212-263-0228; Email: Nalini.Jeet@nyulangone.org
• Study Contact Backup: Name: Yuan-hao Wu; Phone Number: 212.263.0307; Email: Yuanhao.Wu@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

I) LBD Patients with or without visual hallucinations

1. 18 - 90 yrs
2. Fluent in English or Spanish
3. Score at least 24 out of 30 on the MoCA
4. 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)

1. 18 - 90 yrs
2. Fluent in English or Spanish
3. Score at least 26 out of 30 on the MoCA

Exclusion Criteria:

I) LBD Patients with or without visual hallucinations

1. History of traumatic brain injury or significant head trauma
2. History of significant neurologic disorders other than Lewy body diseases
3. Meets DSM-IV criteria for substance abuse or dependence
4. For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form

II) Age-matched controls (healthy volunteers)

1. History of traumatic brain injury or significant head trauma
2. History of significant neurologic disorders other than Lewy body diseases
3. Meets DSM-IV criteria for substance abuse or dependence
4. For MRI studies, any contraindication to MRI as determined by the MRI Safety Screening Form

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Behavioral Tasks; Delivered as part of outpatient experimental sessions.; Other: MRI/MEG Scans; Delivered as part of outpatient experimental sessions.
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.	Behavioral: Behavioral Tasks; Delivered as part of outpatient experimental sessions.; Other: MRI/MEG Scans; Delivered as part of outpatient experimental sessions.
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.	Behavioral: Behavioral Tasks; Delivered as part of outpatient experimental sessions.; Other: MRI/MEG Scans; Delivered as part of outpatient experimental sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Biyu He, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2026
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): August 31, 2031

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 24, 2026
• First Posted (Actual): September 30, 2026

Study Record Updates

• Last Update Posted (Actual): September 30, 2026
• Last Update Submitted That Met QC Criteria: September 24, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Lewy Body Disease; Hallucinations
• Other Study ID Numbers: 15-01323; 1R01NS148898 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

Drug and device information, study documents

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