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Visual Hallucinations in Lewy Body Diseases

24 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

234

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10016
        • Werving
        • NYU Langone Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Gedragsmatig: Behavioral Tasks

Delivered as part of outpatient experimental sessions.

Ander: 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.
Gedragsmatig: Behavioral Tasks

Delivered as part of outpatient experimental sessions.

Ander: 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.
Gedragsmatig: Behavioral Tasks

Delivered as part of outpatient experimental sessions.

Ander: MRI/MEG Scans

Delivered as part of outpatient experimental sessions.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in recognition rate
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

NYU Langone Health

Medewerkers

National Institute of Neurological Disorders and Stroke (NINDS)

Onderzoekers

  • Hoofdonderzoeker: Biyu He, PhD, NYU Langone Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 september 2026

Primaire voltooiing (Geschat)

31 augustus 2031

Studie voltooiing (Geschat)

31 augustus 2031

Studieregistratiedata

Eerst ingediend

16 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 september 2026

Eerst geplaatst (Werkelijk)

30 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 15-01323
  • 1R01NS148898 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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