Perception in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Perception in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483036
• Other study ID #: 6350X
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: Boston University Charles River Campus
• Contact: Shraddha B Kinger, MA
• Phone: 617-901-6168
• Email: shradk[@]bu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallucinations
• Parkinson Disease
• Parkinson's Disease
• Perception
• Visual Hallucination

Locations

Country	Name	City	State
United States	Vision and Cognition Laboratory, Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

References & Publications (27)

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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. Erratum In: Drugs. 2016 Sep;76(13):1319. Dosage error in article text. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Nat Rev Neurosci. 2017 Aug;18(8):509. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Penn Online Evaluation of Migraine (POEM)	Assesses headaches and migraine-related history.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	NIH NeuroQoL measures	Assesses health-related quality of life in adults with neurological disorders. Higher scores on the sub-scales indicate worse outcomes.	Baseline
Primary	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
Primary	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