Parkinson's Disease Clinical Trial
Official title:
Perception in Parkinson's Disease
NCT number | NCT05483036 |
Other study ID # | 6350X |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | September 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vision and Cognition Laboratory, Boston University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus |
United States,
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. — View Citation
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. — View Citation
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
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. — View Citation
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
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. — View Citation
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
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. — View Citation
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. — View Citation
* Note: There are 27 references in all — Click here to view all references
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 |
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