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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nalini Jeet
- Número de teléfono: 212-263-0228
- Correo electrónico: Nalini.Jeet@nyulangone.org
Copia de seguridad de contactos de estudio
- Nombre: Yuan-hao Wu
- Número de teléfono: 212.263.0307
- Correo electrónico: Yuanhao.Wu@nyulangone.org
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10016
- Reclutamiento
- NYU Langone Health
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in recognition rate
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Biyu He, PhD, NYU Langone Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Demencia
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedad de Parkinson
- Enfermedad de cuerpos de Lewy
- Alucinaciones
Otros números de identificación del estudio
- 15-01323
- 1R01NS148898 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
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.
Criterios de acceso compartido de IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .