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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Behavioral Tasks
BehavioralDelivered as part of outpatient experimental sessions.
MRI/MEG Scans
Other interventionDelivered as part of outpatient experimental sessions.
Treatment groups
Trial outcomes
Primary outcomes
Changes in recognition rate
Behavioral responses assessed by changes in recognition rate from pre- to post-disambiguation stage.
Euclidean distance in neural activity patterns
Neural response patterns assessed by Euclidean distance in neural activity pattern between pre- and post-disambiguation stages.
Sponsors and contacts
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NYU Langone Health
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator