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Visual Hallucinations in Lewy Body Diseases

Understanding Neural Mechanisms Underlying Visual Hallucinations in Lewy Body Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07849413
Enrollment
234
Registered
2026-09-30
Start date
2026-09-15
Completion date
2031-08-31
Last updated
2026-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lewy Body Disease, Lewy Body Dementia, Parkinson Disease, Parkinson Disease Dementia, Visual Hallucinations

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.

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.

Interventions

Delivered as part of outpatient experimental sessions.

OTHERMRI/MEG Scans

Delivered as part of outpatient experimental sessions.

Sponsors

NYU Langone Health
Lead SponsorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in recognition ratePre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.
Euclidean distance in neural activity patternsPre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)Neural response patterns assessed by Euclidean distance in neural activity pattern between pre- and post-disambiguation stages.

Countries

United States

Contacts

CONTACTYuan-hao Wu
Yuanhao.Wu@nyulangone.org212.263.0307
CONTACTNalini Jeet
Nalini.Jeet@nyulangone.org212-263-0228
PRINCIPAL_INVESTIGATORBiyu He, PhD

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 1, 2026