NCT05169827|Completed
Cerebral Contributions to Symptom Progression in PD
How Cerebral Plasticity Shapes Symptom Progression in Parkinson's Disease: a Longitudinal Neuroimaging Study
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How Cerebral Plasticity Shapes Symptom Progression in Parkinson's Disease: a Longitudinal Neuroimaging Study
Sponsor study identifier
observational
115
1 country
1
Study Start
December 1, 2019
Actual (reported)Primary Completion
November 28, 2023
Actual (reported)Study Completion
November 28, 2023
Actual (reported)Motor symptom progression in early-stage Parkinson's disease varies substantially between individual patients. This progression correlates poorly with striatal dopamine depletion, which is largely complete four years post-diagnosis. Identification of alternative mechanisms, such as cortical compensatory processes, may enable more accurate predictions of individual motor progression.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 28, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2019
Actual (reported)March 30, 2021
Actual (reported)December 27, 2021
Actual (reported)November 28, 2023
Actual (reported)November 28, 2023
Actual (reported)Mid-term disease progression in terms of overall motor symptoms
Change in Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score, measured in off state. This scale assesses 18 motor symptoms (33 items) that are specific for Parkinson's disease. Item scores range from 0 to 4 and are summed, resulting in a total score ranging from 0 to 132, with higher scores representing worse outcomes.
Baseline and 2 years
Mid-term disease progression in terms of bradykinesia and rigidity
Change in Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score, measured in off state. This scale assesses 18 motor symptoms (33 items) that are specific for Parkinson's disease. Item scores range from 0 to 4. 17 items assessing bradykinesia and rigidity and are summed, resulting in a total score ranging from 0 to 68, with higher scores representing worse outcomes.
Baseline and 2 years
Patients with PD who have previously been included in the Personalized Parkinson Project return for fMRI measurements in an off-medicated state (12h withdrawal). N = 60. The PD-OFF group undergoes a single testing session.
Healthy individuals who are matched on age and sex with respect to the PD-OFF group. N = 60. The healthy group undergoes baseline and two year follow-up testing sessions.
Patients with PD who are included in the Personalized Parkinson Project. N = 360. Available data will be used. There will be no further data collection in this group.
Any person with, or without, Parkinson's disease who meets the inclusion criteria and does not meet the exclusion criteria
Donders institute for brain, cognition and behaviour
Nijmegen, Gelderland, 6500HB, Netherlands
Buhmann C, Binkofski F, Klein C, Buchel C, van Eimeren T, Erdmann C, Hedrich K, Kasten M, Hagenah J, Deuschl G, Pramstaller PP, Siebner HR. Motor reorganization in asymptomatic carriers of a single mutant Parkin allele: a human model for presymptomatic parkinsonism. Brain. 2005 Oct;128(Pt 10):2281-90. doi: 10.1093/brain/awh572. Epub 2005 Jun 9.
Helmich RC, de Lange FP, Bloem BR, Toni I. Cerebral compensation during motor imagery in Parkinson's disease. Neuropsychologia. 2007 Jun 11;45(10):2201-15. doi: 10.1016/j.neuropsychologia.2007.02.024. Epub 2007 Mar 7.
Rick C Helmich, MD, PhD
Donders Centre for Cognitive Neuroimaging
Bastiaan R Bloem, MD, PhD
Radboud University Medical Center, Department of Neurology
115 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2021
First Posted
December 27, 2021
Study Start
December 1, 2019
Actual (reported)The Effects of Mindfulness-based Cognitive Therapy in People With Parkinson's Disease
Real-PD Trial: Development of Clinical Prognostic Models for Parkinson's Disease
Contact the study team to confirm eligibility.
Herz DM, Eickhoff SB, Lokkegaard A, Siebner HR. Functional neuroimaging of motor control in Parkinson's disease: a meta-analysis. Hum Brain Mapp. 2014 Jul;35(7):3227-37. doi: 10.1002/hbm.22397. Epub 2013 Oct 5.
Herz DM, Meder D, Camilleri JA, Eickhoff SB, Siebner HR. Brain Motor Network Changes in Parkinson's Disease: Evidence from Meta-Analytic Modeling. Mov Disord. 2021 May;36(5):1180-1190. doi: 10.1002/mds.28468. Epub 2021 Jan 11.
Kordower JH, Olanow CW, Dodiya HB, Chu Y, Beach TG, Adler CH, Halliday GM, Bartus RT. Disease duration and the integrity of the nigrostriatal system in Parkinson's disease. Brain. 2013 Aug;136(Pt 8):2419-31. doi: 10.1093/brain/awt192.
Michely J, Volz LJ, Barbe MT, Hoffstaedter F, Viswanathan S, Timmermann L, Eickhoff SB, Fink GR, Grefkes C. Dopaminergic modulation of motor network dynamics in Parkinson's disease. Brain. 2015 Mar;138(Pt 3):664-78. doi: 10.1093/brain/awu381. Epub 2015 Jan 6.
van Nuenen BF, Helmich RC, Buenen N, van de Warrenburg BP, Bloem BR, Toni I. Compensatory activity in the extrastriate body area of Parkinson's disease patients. J Neurosci. 2012 Jul 11;32(28):9546-53. doi: 10.1523/JNEUROSCI.0335-12.2012.
van Nuenen BF, van Eimeren T, van der Vegt JP, Buhmann C, Klein C, Bloem BR, Siebner HR. Mapping preclinical compensation in Parkinson's disease: an imaging genomics approach. Mov Disord. 2009;24 Suppl 2:S703-10. doi: 10.1002/mds.22635.
Obeso JA, Rodriguez-Oroz MC, Rodriguez M, Lanciego JL, Artieda J, Gonzalo N, Olanow CW. Pathophysiology of the basal ganglia in Parkinson's disease. Trends Neurosci. 2000 Oct;23(10 Suppl):S8-19. doi: 10.1016/s1471-1931(00)00028-8.
Palop JJ, Chin J, Mucke L. A network dysfunction perspective on neurodegenerative diseases. Nature. 2006 Oct 19;443(7113):768-73. doi: 10.1038/nature05289.
Pirker W, Holler I, Gerschlager W, Asenbaum S, Zettinig G, Brucke T. Measuring the rate of progression of Parkinson's disease over a 5-year period with beta-CIT SPECT. Mov Disord. 2003 Nov;18(11):1266-72. doi: 10.1002/mds.10531.
Redgrave P, Rodriguez M, Smith Y, Rodriguez-Oroz MC, Lehericy S, Bergman H, Agid Y, DeLong MR, Obeso JA. Goal-directed and habitual control in the basal ganglia: implications for Parkinson's disease. Nat Rev Neurosci. 2010 Nov;11(11):760-72. doi: 10.1038/nrn2915. Epub 2010 Oct 14.
Primary Completion
November 28, 2023
Actual (reported)Study Completion
November 28, 2023
Actual (reported)Last Updated
February 21, 2025
Record last verified: 2025-02
See plan description for the Personalized Parkinson Project. In addition to these steps, we will make our statistical analysis plan and analytic code available to researchers that specifically focus on data related to the action selection task.
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Source: ClinicalTrials.gov.
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