NCT03137238

Brief Summary

Parkinson's Disease as well as being a disorder of motor function also causes a wide range of non-motor disturbances many of which are involved in the prodromal stage prior to the onset of motor symptoms. Abnormal perception in the visual and in other domains is increasingly being recognized. Control of the movement of our bodies in space involves perception of self-motion which is dependent on the processing and integration of multimodality information from the kinesthetic, proprioceptive, visual (mostly optic flow) and vestibular systems. Dysfunction in this process may contribute to disturbed postural control and thus result in gait abnormalities and falls which are common as Parkinson's disease progresses, is difficult to treat and causes disability and a loss of independence. The integration of information from different modalities ("multisensory integration") is vital for intact perception of the world. Theoretical studies, based on Bayesian statistics, have provided a framework to study multisensory-integration with predictions for an 'optimal' strategy. Many human and animal studies have demonstrated near optimal cue-integration. Yet, while multisensory integration is an active topic of research in normal brain function, with well-established tools, it has not been studied in PD. The investigators hypothesize, based on the apparent over-dependence in PD on visual cues that PD patients will demonstrate defective multisensory integration. This can have profound effects on basic motor functions. Furthermore, based on both visual and vestibular abnormalities (described above) the basic (uni-sensory) performance may also be degraded in PD. In this study the investigators will observe the basic (uni-sensory) and the multisensory integration of visual and vestibular perception of self-motion within the same experiment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

April 18, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

April 18, 2017

Last Update Submit

March 16, 2021

Conditions

Keywords

Self-motion perceptionOptic flowVestibular systemMultisensory integrationParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Change in multisensory integration

    Psychometric plot will be defined as the proportion of rightward choices as a function of heading angle and calculated by fitting the data with a cumulative Gaussian distribution function. Separate psychometric functions will construct for visual, vestibular, and combined cues. The psychophysical threshold and point of subjective equality will be the SD (σ) and mean (μ), respectively, deduced from the fitted distribution function. We will compare the actual weights patients gave to each cue to the predicted one, and thus will be able to study if their integration was optimal, compere to healthy participants. No change is expected to occur for control group. For the PD group, there may be an effect of antiparkinsonian medications, hence PD participants will be tested once after taking the regular antiparkinsonian medications and once after a 12 hour period of not taking any antiparkinsonian medication.

    All participants will come for two visits, each visit will take 1.5 - 2 hours 4 days and two weeks apart. Measurements will be taken in a continuous fashion during these visits only.

Study Arms (4)

Early_PD

People with Parkinson's disease in the early stages with low doses of antiparkinsonian medication and no motor fluctuations.

Other: Investigation of self-perception in Parkinson's disease

Advanced_PD

People with advanced Parkinson's disease with motor fluctuations.

Other: Investigation of self-perception in Parkinson's disease

Early_controls

Healthy participants matched for age and gender to the 'Early\_PD' group.

Other: Investigation of self-perception in Parkinson's disease

Advanced_controls

Healthy participants matched for age and gender to the 'Advanced\_PD' group.

Other: Investigation of self-perception in Parkinson's disease

Interventions

There is no therapeutic intervention.

Advanced_PDAdvanced_controlsEarly_PDEarly_controls

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD patients and healthy subjects.

You may qualify if:

  • Both groups will be screened using the Montreal Cognitive Assessment (MoCA) test, and only individuals with normal cognitive function will be included in the study (above 22)

You may not qualify if:

  • PD patients determined clinically to be at high risk of falling, indicated by scores of 3 or more on items 2.12, 2.13, 3.10, 3.11 and 3.12 of the Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS- UPDRS).
  • Participants under 18 years old
  • Participants with vertigo or other active vestibular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

Bar Ilan University

Ramat Gan, 5290002, Israel

RECRUITING

Related Publications (27)

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    PMID: 18957454BACKGROUND
  • Fetsch CR, Turner AH, DeAngelis GC, Angelaki DE. Dynamic reweighting of visual and vestibular cues during self-motion perception. J Neurosci. 2009 Dec 9;29(49):15601-12. doi: 10.1523/JNEUROSCI.2574-09.2009.

    PMID: 20007484BACKGROUND
  • Gu Y, Angelaki DE, Deangelis GC. Neural correlates of multisensory cue integration in macaque MSTd. Nat Neurosci. 2008 Oct;11(10):1201-10. doi: 10.1038/nn.2191. Epub 2008 Sep 7.

    PMID: 18776893BACKGROUND
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    PMID: 23957375BACKGROUND
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    PMID: 25941373BACKGROUND
  • Zaidel A, Spivak A, Grieb B, Bergman H, Israel Z. Subthalamic span of beta oscillations predicts deep brain stimulation efficacy for patients with Parkinson's disease. Brain. 2010 Jul;133(Pt 7):2007-21. doi: 10.1093/brain/awq144. Epub 2010 Jun 9.

    PMID: 20534648BACKGROUND
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    PMID: 27412389BACKGROUND
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    PMID: 26474316BACKGROUND
  • Montse A, Pere V, Carme J, Francesc V, Eduardo T. Visuospatial deficits in Parkinson's disease assessed by judgment of line orientation test: error analyses and practice effects. J Clin Exp Neuropsychol. 2001 Oct;23(5):592-8. doi: 10.1076/jcen.23.5.592.1248.

    PMID: 11778636BACKGROUND
  • Morgan ML, Deangelis GC, Angelaki DE. Multisensory integration in macaque visual cortex depends on cue reliability. Neuron. 2008 Aug 28;59(4):662-73. doi: 10.1016/j.neuron.2008.06.024.

    PMID: 18760701BACKGROUND
  • Stein BE, Stanford TR. Multisensory integration: current issues from the perspective of the single neuron. Nat Rev Neurosci. 2008 Apr;9(4):255-66. doi: 10.1038/nrn2331.

    PMID: 18354398BACKGROUND
  • Revonsuo A, Portin R, Koivikko L, Rinne JO, Rinne UK. Slowing of information processing in Parkinson's disease. Brain Cogn. 1993 Jan;21(1):87-110. doi: 10.1006/brcg.1993.1007.

    PMID: 8424865BACKGROUND
  • Sprengelmeyer R, Young AW, Mahn K, Schroeder U, Woitalla D, Buttner T, Kuhn W, Przuntek H. Facial expression recognition in people with medicated and unmedicated Parkinson's disease. Neuropsychologia. 2003;41(8):1047-57. doi: 10.1016/s0028-3932(02)00295-6.

    PMID: 12667540BACKGROUND
  • van der Hoorn A, Renken RJ, Leenders KL, de Jong BM. Parkinson-related changes of activation in visuomotor brain regions during perceived forward self-motion. PLoS One. 2014 Apr 22;9(4):e95861. doi: 10.1371/journal.pone.0095861. eCollection 2014.

    PMID: 24755754BACKGROUND
  • Ricciardi L, Visco-Comandini F, Erro R, Morgante F, Bologna M, Fasano A, Ricciardi D, Edwards MJ, Kilner J. Facial Emotion Recognition and Expression in Parkinson's Disease: An Emotional Mirror Mechanism? PLoS One. 2017 Jan 9;12(1):e0169110. doi: 10.1371/journal.pone.0169110. eCollection 2017.

    PMID: 28068393BACKGROUND
  • Knill DC, Pouget A. The Bayesian brain: the role of uncertainty in neural coding and computation. Trends Neurosci. 2004 Dec;27(12):712-9. doi: 10.1016/j.tins.2004.10.007.

    PMID: 15541511BACKGROUND
  • Konczak J, Corcos DM, Horak F, Poizner H, Shapiro M, Tuite P, Volkmann J, Maschke M. Proprioception and motor control in Parkinson's disease. J Mot Behav. 2009 Nov;41(6):543-52. doi: 10.3200/35-09-002.

    PMID: 19592360BACKGROUND
  • Bertolini G, Wicki A, Baumann CR, Straumann D, Palla A. Impaired tilt perception in Parkinson's disease: a central vestibular integration failure. PLoS One. 2015 Apr 15;10(4):e0124253. doi: 10.1371/journal.pone.0124253. eCollection 2015.

    PMID: 25874868BACKGROUND
  • Bodis-Wollner I, Yahr MD. Measurements of visual evoked potentials in Parkinson's disease. Brain. 1978 Dec;101(4):661-71. doi: 10.1093/brain/101.4.661.

    PMID: 737524BACKGROUND
  • Bodis-Wollner I, Marx MS, Mitra S, Bobak P, Mylin L, Yahr M. Visual dysfunction in Parkinson's disease. Loss in spatiotemporal contrast sensitivity. Brain. 1987 Dec;110 ( Pt 6):1675-98. doi: 10.1093/brain/110.6.1675.

    PMID: 3427405BACKGROUND
  • Fushiki H, Kobayashi K, Asai M, Watanabe Y. Influence of visually induced self-motion on postural stability. Acta Otolaryngol. 2005 Jan;125(1):60-4. doi: 10.1080/00016480410015794.

    PMID: 15799576BACKGROUND
  • Maier F, Prigatano GP, Kalbe E, Barbe MT, Eggers C, Lewis CJ, Burns RS, Morrone-Strupinsky J, Moguel-Cobos G, Fink GR, Timmermann L. Impaired self-awareness of motor deficits in Parkinson's disease: association with motor asymmetry and motor phenotypes. Mov Disord. 2012 Sep 15;27(11):1443-7. doi: 10.1002/mds.25079. Epub 2012 Jun 18.

    PMID: 22711290BACKGROUND
  • Clark JP, Adams SG, Dykstra AD, Moodie S, Jog M. Loudness perception and speech intensity control in Parkinson's disease. J Commun Disord. 2014 Sep-Oct;51:1-12. doi: 10.1016/j.jcomdis.2014.08.001. Epub 2014 Aug 23.

    PMID: 25194745BACKGROUND
  • Carandini M, Churchland AK. Probing perceptual decisions in rodents. Nat Neurosci. 2013 Jul;16(7):824-31. doi: 10.1038/nn.3410. Epub 2013 Jun 25.

    PMID: 23799475BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Simon Israeli-Korn, Dr

    Institute of Movement Disorders, Sheba medical center, Tel-Hashomer

    PRINCIPAL INVESTIGATOR
  • Adam Zaidel, PhD

    Gonda Multidisciplinary Brain Research Center at Bar-Ilan University, Ramat-Gan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2017

First Posted

May 2, 2017

Study Start

May 1, 2017

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

March 17, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

There is currently no plan for sharing IPD

Locations