Clincosm LogoSign in Get a demo

Perceptual Predictors of Visual Hallucinations in Parkinson's Disease

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05483036
Collaborator
(none)
60
Enrollment
1
Location
25
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Visual hallucinations (VH) are among the most distressing of the non-motor symptoms of Parkinson's disease (PD). The investigators plan to examine the relation of perceptual variables-basic vision, unusual perceptual experiences-to relevant functional variables such as cognition, mood, and alertness/sleepiness in an online sample of persons with Parkinson's disease (PwPD). It is hypothesized that unusual perceptual experiences will relate significantly to the selected variables. This is an observational study only, and not an interventional study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Visual Hallucinations (VH) are among the most distressing of the non-motor symptoms of Parkinson's disease (PD), as well as being prevalent, with estimates ranging up to 75%. Researchers have identified numerous correlates of VH in PD including older age, longer and more severe disease, certain dopaminergic medications, mood disturbances, sleep disorders, and altered visual processing. Abnormal visual processing is likely to be an important contributor and may even predict the development of VH. Persons with Parkinson's disease (PwPD) who report VH typically exhibit compromised visuospatial function and visual object perception. Studies using novel behavioral designs have shown abnormal perception of ambiguous or bistable objects in PD-VH. Recently, the investigators demonstrated that PwPD with VH, especially more complex VH, had poorer contrast sensitivity than PwPD without VH, and that their object identification could be normalized with enhanced contrast.

    Brain imaging studies have shown structural and functional changes in regions associated with visual processing in PwPD with VH. These studies, coupled with behavioral research pointing to impaired object recognition, have served as the basis for including impaired visual processing (both low-level and high-order visual regions) in theoretical models of VH. Minor hallucinations, too, could be early markers of larger-scale network dysfunction, cognitive impairment, depression, REM sleep behavior disorder, and formed (complex). Because of this possible predictive relation, the investigators include minor hallucinations when referring to VH.

    An intriguing question is whether perception-based, non-pharmacological interventions may change the type or reduce the frequency of occurrence of VH in PD. A necessary first step before designing perception-based interventions is to identify markers: perceptual abnormalities that may correlate with, and possibly predict, the development of VH. A potential perceptual marker that has gained traction with researchers studying VH is the response to pareidolic images. These are images that are not meant to represent particular objects, faces, or scenes, but are nevertheless interpreted as being meaningful by persons with PD and especially those with PD-VH. The tendency to see meaning in meaningless images-pareidolia-- has been demonstrated in PD-VH and related disorders and been proposed as a marker for VH, which generally cannot be made to appear on-demand in the lab.

    For this study, the investigators propose to conduct an online study of PwPD (proposing a total of 60 participants) to examine the relations among variables that may relate to VH in PD. Participants will be recruited via online research platforms such as the Fox Trial Finder, as in our previous studies. Those PwPD who express interest will be sent a link to the online assessments (Qualtrics). The investigators will collect demographic and health information, followed by questionnaires assessing unusual perceptual experiences, mood, motivation, sleep, fatigue and quality of life. This is an observational study only, and not an interventional study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Perceptual Predictors of Visual Hallucinations in Parkinson's Disease
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Persons with Parkinson's disease (PwPD)

    Outcome Measures

    Primary Outcome Measures

    1. Noise Pareidolia Test [Baseline]

      Assesses tendency to see meaningful objects such as faces, animals, and objects in ambiguous patterns. Higher scores (on items with no face) indicate a higher number of pareidolic responses.

    2. Mooney Faces [Baseline]

      Assesses the ability to see an upright, inverted, or scrambled face in a black and white pattern. Higher scores (on items with no face) indicate a higher number of pareidolic responses.

    3. BU Hallucinations and Unusual Perceptual Experiences questionnaire (BU-HUPE) [Baseline]

      Assesses different types of visual hallucinations - simple VH; illusions; minor hallucinations: vivid sense of presence or movement in periphery (passage); and complex VH (e.g., people, animals, objects), as well as temporal and descriptive characteristics of the hallucinations. Higher scores indicate more unusual perceptual experiences.

    4. Prodromal Questionnaire, Brief Version (PQ-B) [Baseline]

      Assesses risk for psychosis by asking about positive symptoms and related distress/impairment. Higher scores indicate higher risk for psychosis and higher related distress.

    5. Parkinson's Disease - Psychotic Symptoms Scale (PD-PSS) [Baseline]

      Assesses the frequency and severity of minor hallucinations (passage hallucinations, presence hallucinations, visual illusions), and structured hallucinations in PD. Higher scores indicate higher frequency of psychotic symptoms.

    6. Penn Online Evaluation of Migraine (POEM) [Baseline]

      Assesses headaches and migraine-related history.

    7. Epworth Sleepiness Scale (ESS) [Baseline]

      Assesses a person's general level of daytime sleepiness. Maximum Score: 24. Higher scores indicate a higher chance of dozing.

    8. Parkinson's Disease Sleep Scale-2 [Baseline]

      Assesses sleep and nocturnal disturbances in Parkinson's disease. Maximum score: 60. Higher scores indicate more frequent sleep disturbances.

    9. Parkinson's Anxiety Scale (PAS) [Baseline]

      Assesses the severity of anxiety symptoms in persons with Parkinson's disease. Maximum score:48. Higher scores indicate more severe anxiety.

    10. Center for Epidemiological Studies Depression Scale (CES-D) [Baseline]

      Assesses depressive symptoms in the general population. Maximum score:60. Higher scores indicate more severe depression.

    11. Parkinson's Disease Questionnaire - 39 (PDQ-39) [Baseline]

      Assesses Parkinson's disease-specific health-related quality of life. Higher scores indicate worse quality of life.

    12. NIH NeuroQoL measures [Baseline]

      Assesses health-related quality of life in adults with neurological disorders. Higher scores on the sub-scales indicate worse outcomes.

    13. The Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) [Baseline]

      Assesses motor and non-motor experiences of daily living in Parkinson's disease. Higher scores indicate increased severity of motor and non-motor symptoms.

    14. Non-Motor Symptoms Questionnaire (NMSQ) [Baseline]

      Assesses a range of non-motor symptoms in Parkinson's disease. Higher scores indicate the presence of more non-motor symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must be at least 40 years old

    • Have a self-reported diagnosis of idiopathic PD

    • Be proficient English speakers

    • Have functional vision

    • Have internet access, and access to a desktop computer or laptop

    Exclusion Criteria:

    • Self-reported poor vision (non-functional range)

    • Lack of access to internet and either a desktop computer or laptop

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vision and Cognition Laboratory, Boston University Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Boston University Charles River Campus

    Investigators

    • Principal Investigator: Alice Cronin-Golomb, PhD, Boston University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alice Cronin-Golomb, Director, Vision and Cognition Laboratory, Boston University Charles River Campus
    ClinicalTrials.gov Identifier:
    NCT05483036
    Other Study ID Numbers:
    • 6350X
    First Posted:
    Aug 1, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Hallucinations

    Study Results

    No Results Posted as of Aug 3, 2022