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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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:
- LBD patients who experience visual hallucinations
- LBD patients who do not have visual hallucinations
- 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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Nalini Jeet
- 전화번호: 212-263-0228
- 이메일: Nalini.Jeet@nyulangone.org
연구 연락처 백업
- 이름: Yuan-hao Wu
- 전화번호: 212.263.0307
- 이메일: Yuanhao.Wu@nyulangone.org
연구 장소
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New York
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New York, New York, 미국, 10016
- 모병
- NYU Langone Health
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
Inclusion Criteria:
I) LBD Patients with or without visual hallucinations
- 18 - 90 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)
- 18 - 90 yrs
- Fluent in English or Spanish
- Score at least 26 out of 30 on the MoCA
Exclusion Criteria:
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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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. |
Delivered as part of outpatient experimental sessions. 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. |
Delivered as part of outpatient experimental sessions. 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. |
Delivered as part of outpatient experimental sessions. Delivered as part of outpatient experimental sessions. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in recognition rate
기간: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
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Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage. |
Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
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Euclidean distance in neural activity patterns
기간: Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
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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)
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Biyu He, PhD, NYU Langone Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 15-01323
- 1R01NS148898 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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