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AzTrials

Parkinson's DiseaseNCT05483036

Perception in Parkinson's Disease

An observational study of Parkinson's Disease and Perception, run by Boston University Charles River Campus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 110 years
How many people
54 participants
Where
1 siteUnited States
Study dates
1 Sep 2022to 1 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: PwPD volunteering for an online study

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vision and Cognition Laboratory, Boston University

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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.

Read the detailed description

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 perception in PD. Those PwPD who express interest will be sent a link to an online survey (Qualtrics). The investigators will collect demographic and health information, followed by questionnaires assessing unusual perceptual experiences, mood, motivation, sleep, fatigue and quality of life. The survey should take roughly 45 minutes to an hour to complete.

Compensation: A $20 Amazon gift card will be offered to those who complete the survey all the way through with good effort.

Medical subject headings
Parkinson Disease, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05483036
Study groupRoleWhat they receive
Persons with Parkinson's disease (PwPD)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. Penn Online Evaluation of Migraine (POEM)

    Assesses headaches and migraine-related history.

    Measured: Baseline

  7. Epworth Sleepiness Scale (ESS)

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

    Measured: Baseline

  8. 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.

    Measured: Baseline

  9. 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.

    Measured: Baseline

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

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

    Measured: Baseline

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

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

    Measured: Baseline

  12. NIH NeuroQoL measures

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

    Measured: Baseline

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion1 May 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05483036
Sponsor's protocol ID
6350X
Status last verified
Aug 2024
First submitted
29 Jul 2022
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28592904
  • 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.

    PubMed 11385004
  • 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.

    PubMed 27312429
  • 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.

    PubMed 10734005
  • 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.

    PubMed 22927195
  • 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.

    PubMed 21617521
  • 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.

    PubMed 19965847
  • 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.

    PubMed 21705027
  • 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.

    PubMed 24480486
  • 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.

    PubMed 25920541
  • 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.

    PubMed 17594330
  • 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.

    PubMed 23843193
  • 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.

    PubMed 15505157
  • 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.

    PubMed 33102741
  • 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.

    PubMed 32213570

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease and Perception, run by Boston University Charles River Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Noise Pareidolia Test (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05483036, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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