NCT05483036

Brief Summary

The investigators plan to examine the relation of perceptual variables-basic vision, unusual perceptual experiences(including but not limited to visual hallucinations)-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. Participants do not need to experience visual hallucinations to be able to participate in this study. This is an observational study only, and not an interventional study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 19, 2025

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

July 29, 2022

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (14)

  • Noise Pareidolia Test

    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.

    Baseline

  • Mooney Faces

    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.

    Baseline

  • BU Hallucinations and Unusual Perceptual Experiences questionnaire (BU-HUPE)

    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.

    Baseline

  • Prodromal Questionnaire, Brief Version (PQ-B)

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

    Baseline

  • Parkinson's Disease - Psychotic Symptoms Scale (PD-PSS)

    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.

    Baseline

  • Penn Online Evaluation of Migraine (POEM)

    Assesses headaches and migraine-related history.

    Baseline

  • Epworth Sleepiness Scale (ESS)

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

    Baseline

  • Parkinson's Disease Sleep Scale-2

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

    Baseline

  • Parkinson's Anxiety Scale (PAS)

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

    Baseline

  • Center for Epidemiological Studies Depression Scale (CES-D)

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

    Baseline

  • Parkinson's Disease Questionnaire - 39 (PDQ-39)

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

    Baseline

  • NIH NeuroQoL measures

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

    Baseline

  • The Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)

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

    Baseline

  • Non-Motor Symptoms Questionnaire (NMSQ)

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

    Baseline

Study Arms (1)

Persons with Parkinson's disease (PwPD)

Eligibility Criteria

Age40 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PwPD volunteering for an online study

You may qualify if:

  • 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

You may not qualify if:

  • Self-reported poor vision (non-functional range)
  • Lack of access to internet and either a desktop computer or laptop

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vision and Cognition Laboratory, Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (27)

  • Schapira AHV, Chaudhuri KR, Jenner P. Non-motor features of Parkinson disease. Nat Rev Neurosci. 2017 Jul;18(7):435-450. doi: 10.1038/nrn.2017.62. Epub 2017 Jun 8.

    PMID: 28592904BACKGROUND
  • Barnes J, David AS. Visual hallucinations in Parkinson's disease: a review and phenomenological survey. J Neurol Neurosurg Psychiatry. 2001 Jun;70(6):727-33. doi: 10.1136/jnnp.70.6.727.

    PMID: 11385004BACKGROUND
  • Chang A, Fox SH. Psychosis in Parkinson's Disease: Epidemiology, Pathophysiology, and Management. Drugs. 2016 Jul;76(11):1093-118. doi: 10.1007/s40265-016-0600-5.

    PMID: 27312429BACKGROUND
  • Fenelon G, Mahieux F, Huon R, Ziegler M. Hallucinations in Parkinson's disease: prevalence, phenomenology and risk factors. Brain. 2000 Apr;123 ( Pt 4):733-45. doi: 10.1093/brain/123.4.733.

    PMID: 10734005BACKGROUND
  • Gibson G, Mottram PG, Burn DJ, Hindle JV, Landau S, Samuel M, Hurt CS, Brown RG, M Wilson KC. Frequency, prevalence, incidence and risk factors associated with visual hallucinations in a sample of patients with Parkinson's disease: a longitudinal 4-year study. Int J Geriatr Psychiatry. 2013 Jun;28(6):626-31. doi: 10.1002/gps.3869. Epub 2012 Aug 28.

    PMID: 22927195BACKGROUND
  • Mack J, Rabins P, Anderson K, Goldstein S, Grill S, Hirsch ES, Lehmann S, Little JT, Margolis RL, Palanci J, Pontone G, Weiss H, Williams JR, Marsh L. Prevalence of psychotic symptoms in a community-based Parkinson disease sample. Am J Geriatr Psychiatry. 2012 Feb;20(2):123-32. doi: 10.1097/JGP.0b013e31821f1b41.

    PMID: 21617521BACKGROUND
  • Ibarretxe-Bilbao N, Ramirez-Ruiz B, Junque C, Marti MJ, Valldeoriola F, Bargallo N, Juanes S, Tolosa E. Differential progression of brain atrophy in Parkinson's disease with and without visual hallucinations. J Neurol Neurosurg Psychiatry. 2010 Jun;81(6):650-7. doi: 10.1136/jnnp.2009.179655. Epub 2009 Dec 3.

    PMID: 19965847BACKGROUND
  • Ibarretxe-Bilbao N, Junque C, Marti MJ, Tolosa E. Cerebral basis of visual hallucinations in Parkinson's disease: structural and functional MRI studies. J Neurol Sci. 2011 Nov 15;310(1-2):79-81. doi: 10.1016/j.jns.2011.06.019. Epub 2011 Jun 25.

    PMID: 21705027BACKGROUND
  • Goldman JG, Stebbins GT, Dinh V, Bernard B, Merkitch D, deToledo-Morrell L, Goetz CG. Visuoperceptive region atrophy independent of cognitive status in patients with Parkinson's disease with hallucinations. Brain. 2014 Mar;137(Pt 3):849-59. doi: 10.1093/brain/awt360. Epub 2014 Jan 29.

    PMID: 24480486BACKGROUND
  • Lenka A, Jhunjhunwala KR, Saini J, Pal PK. Structural and functional neuroimaging in patients with Parkinson's disease and visual hallucinations: A critical review. Parkinsonism Relat Disord. 2015 Jul;21(7):683-91. doi: 10.1016/j.parkreldis.2015.04.005. Epub 2015 Apr 17.

    PMID: 25920541BACKGROUND
  • Ramirez-Ruiz B, Marti MJ, Tolosa E, Gimenez M, Bargallo N, Valldeoriola F, Junque C. Cerebral atrophy in Parkinson's disease patients with visual hallucinations. Eur J Neurol. 2007 Jul;14(7):750-6. doi: 10.1111/j.1468-1331.2007.01768.x.

    PMID: 17594330BACKGROUND
  • Goetz CG, Vaughan CL, Goldman JG, Stebbins GT. I finally see what you see: Parkinson's disease visual hallucinations captured with functional neuroimaging. Mov Disord. 2014 Jan;29(1):115-7. doi: 10.1002/mds.25554. Epub 2013 Jul 10.

    PMID: 23843193BACKGROUND
  • Stebbins GT, Goetz CG, Carrillo MC, Bangen KJ, Turner DA, Glover GH, Gabrieli JD. Altered cortical visual processing in PD with hallucinations: an fMRI study. Neurology. 2004 Oct 26;63(8):1409-16. doi: 10.1212/01.wnl.0000141853.27081.bd.

    PMID: 15505157BACKGROUND
  • Weil RS, Reeves S. Hallucinations in Parkinson's disease: new insights into mechanisms and treatments. Adv Clin Neurosci Rehabil. 2020 Jul 13;19(4):ONNS5189. doi: 10.47795/ONNS5189. eCollection 2020 Summer.

    PMID: 33102741BACKGROUND
  • O'Brien J, Taylor JP, Ballard C, Barker RA, Bradley C, Burns A, Collerton D, Dave S, Dudley R, Francis P, Gibbons A, Harris K, Lawrence V, Leroi I, McKeith I, Michaelides M, Naik C, O'Callaghan C, Olsen K, Onofrj M, Pinto R, Russell G, Swann P, Thomas A, Urwyler P, Weil RS, Ffytche D. Visual hallucinations in neurological and ophthalmological disease: pathophysiology and management. J Neurol Neurosurg Psychiatry. 2020 May;91(5):512-519. doi: 10.1136/jnnp-2019-322702. Epub 2020 Mar 25.

    PMID: 32213570BACKGROUND
  • Zhu K, van Hilten JJ, Putter H, Marinus J. Risk factors for hallucinations in Parkinson's disease: results from a large prospective cohort study. Mov Disord. 2013 Jun;28(6):755-62. doi: 10.1002/mds.25389. Epub 2013 Mar 20.

    PMID: 23520046BACKGROUND
  • Ffytche DH, Pereira JB, Ballard C, Chaudhuri KR, Weintraub D, Aarsland D. Risk factors for early psychosis in PD: insights from the Parkinson's Progression Markers Initiative. J Neurol Neurosurg Psychiatry. 2017 Apr;88(4):325-331. doi: 10.1136/jnnp-2016-314832.

    PMID: 28315846BACKGROUND
  • Muller AJ, Shine JM, Halliday GM, Lewis SJ. Visual hallucinations in Parkinson's disease: theoretical models. Mov Disord. 2014 Nov;29(13):1591-8. doi: 10.1002/mds.26004. Epub 2014 Aug 22.

    PMID: 25154807BACKGROUND
  • Schwartzman D, Maravic K, Kranczioch C, Barnes J. Altered early visual processing components in hallucination-prone individuals. Neuroreport. 2008 Jun 11;19(9):933-7. doi: 10.1097/WNR.0b013e328301a640.

    PMID: 18520996BACKGROUND
  • Archibald NK, Clarke MP, Mosimann UP, Burn DJ. The retina in Parkinson's disease. Brain. 2009 May;132(Pt 5):1128-45. doi: 10.1093/brain/awp068. Epub 2009 Mar 31.

    PMID: 19336464BACKGROUND
  • Davidsdottir S, Cronin-Golomb A, Lee A. Visual and spatial symptoms in Parkinson's disease. Vision Res. 2005 May;45(10):1285-96. doi: 10.1016/j.visres.2004.11.006. Epub 2004 Dec 16.

    PMID: 15733961BACKGROUND
  • Diederich NJ, Goetz CG, Raman R, Pappert EJ, Leurgans S, Piery V. Poor visual discrimination and visual hallucinations in Parkinson's disease. Clin Neuropharmacol. 1998 Sep-Oct;21(5):289-95.

    PMID: 9789709BACKGROUND
  • Diaz-Santos M, Monge ZA, Salazar RD, Gilmore GC, Neargarder S, Cronin-Golomb A. Increasing Contrast Improves Object Perception in Parkinson's Disease with Visual Hallucinations. Mov Disord Clin Pract. 2020 Nov 17;8(1):51-59. doi: 10.1002/mdc3.13104. eCollection 2021 Jan.

    PMID: 33426159BACKGROUND
  • Mamiya Y, Nishio Y, Watanabe H, Yokoi K, Uchiyama M, Baba T, Iizuka O, Kanno S, Kamimura N, Kazui H, Hashimoto M, Ikeda M, Takeshita C, Shimomura T, Mori E. The Pareidolia Test: A Simple Neuropsychological Test Measuring Visual Hallucination-Like Illusions. PLoS One. 2016 May 12;11(5):e0154713. doi: 10.1371/journal.pone.0154713. eCollection 2016.

    PMID: 27171377BACKGROUND
  • Uchiyama M, Nishio Y, Yokoi K, Hosokai Y, Takeda A, Mori E. Pareidolia in Parkinson's disease without dementia: A positron emission tomography study. Parkinsonism Relat Disord. 2015 Jun;21(6):603-9. doi: 10.1016/j.parkreldis.2015.03.020. Epub 2015 Mar 31.

    PMID: 25864093BACKGROUND
  • Murakami H, Shiraishi T, Umehara T, Omoto S, Takahashi M, Motegi H, Maku T, Sato T, Takatsu H, Komatsu T, Bono K, Sakai K, Mitsumura H, Iguchi Y. Face pareidolia is associated with right striatal dysfunction in drug-naive patients with Parkinson's disease. Neurol Sci. 2021 Dec;42(12):5327-5334. doi: 10.1007/s10072-021-05238-7. Epub 2021 Apr 22.

    PMID: 33884529BACKGROUND
  • Watanabe H, Nishio Y, Mamiya Y, Narita W, Iizuka O, Baba T, Takeda A, Shimomura T, Mori E. Negative mood invites psychotic false perception in dementia. PLoS One. 2018 Jun 1;13(6):e0197968. doi: 10.1371/journal.pone.0197968. eCollection 2018.

    PMID: 29856844BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseHallucinations

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alice Cronin-Golomb, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Vision and Cognition Laboratory

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 1, 2022

Study Start

September 1, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

September 19, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations