Visual Hallucinations in Lewy Body Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Behavioral Tasks

    Behavioral

    Delivered as part of outpatient experimental sessions.

  • MRI/MEG Scans

    Other intervention

    Delivered as part of outpatient experimental sessions.

Treatment groups

234 Participants
are divided into 3 treatment groups
Group A: Patients with Lewy Body Diseases who experience visual hallucinations2 interventions
Group B: Patients with Lewy Body Diseases who do not experience visual hallucinations2 interventions
Group C: Age-matched controls2 interventions

Trial outcomes

Primary outcomes

1

Changes in recognition rate

Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.

Time frame
Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)
2

Euclidean distance in neural activity patterns

Neural response patterns assessed by Euclidean distance in neural activity pattern between pre- and post-disambiguation stages.

Time frame
Pre-Disambiguation Stage, Post-Disambiguation Stage (Study Visit: 1 Day)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator