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Visual Hallucinations in Lewy Body Diseases

2026年9月24日 更新者：NYU Langone Health

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

234

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • New York
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Health

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
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.
行为的：Behavioral Tasks

Delivered as part of outpatient experimental sessions.

其他：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.
行为的：Behavioral Tasks

Delivered as part of outpatient experimental sessions.

其他：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.
行为的：Behavioral Tasks

Delivered as part of outpatient experimental sessions.

其他：MRI/MEG Scans

Delivered as part of outpatient experimental sessions.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Changes in recognition rate
大体时间：Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)

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
大体时间：Pre-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.
Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

NYU Langone Health

合作者

National Institute of Neurological Disorders and Stroke (NINDS)

调查人员

  • 首席研究员：Biyu He, PhD、NYU Langone Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月15日

初级完成 (估计的)

2031年8月31日

研究完成 (估计的)

2031年8月31日

研究注册日期

首次提交

2026年9月16日

首先提交符合 QC 标准的

2026年9月24日

首次发布 (实际的)

2026年9月30日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 15-01323
  • 1R01NS148898 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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 共享访问标准

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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