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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Nalini Jeet
- Telefonnummer: 212-263-0228
- E-post: Nalini.Jeet@nyulangone.org
Studera Kontakt Backup
- Namn: Yuan-hao Wu
- Telefonnummer: 212.263.0307
- E-post: Yuanhao.Wu@nyulangone.org
Studieorter
-
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New York
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New York, New York, Förenta staterna, 10016
- Rekrytering
- NYU Langone Health
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in recognition rate
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Biyu He, PhD, NYU Langone Health
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Synukleinopatier
- Neurologiska manifestationer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Mentala störningar
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Demens
- Neurodegenerativa sjukdomar
- Rörelsestörningar
- Parkinsons sjukdom
- Basala ganglia sjukdomar
- Perceptuella störningar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Parkinsons sjukdom
- Lewy Body Disease
- Hallucinationer
Andra studie-ID-nummer
- 15-01323
- 1R01NS148898 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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
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