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Recruiting NCT06161636

Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease

— Observational Parkinson Disease Healthy Parkinsonian Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson Disease, Healthy, Parkinsonian Syndromes. Basic parameters: 50 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The working hypotheses are as follows: #1 The processing of performance signals by automated lognormal segmentation and the extraction of the parameters of interest will make it possible to distinguish groups of patients from healthy elderly subjects. #2 The three instrumental approaches will not have the same degree of reliability as a predictive biomarker of clinical diagnosis established by consensus.

Detailed description

The strength of this study is to compares three refined parametric approaches drawn from functions mediated by very different neuromuscular programs (visually guided voluntary movement control to perform trajectories with the hand or arm versus vocal control) among two groups of patients and a healthy group. Its weakness lies in the lack of multimodal methods to accurately confirm clinical diagnosis and the predictive reliability of patient performance. These modalities are too costly to be included in this project. However, different oculovisual measurement standards such as optical coherence tomography, hyperspectral imaging (OPTINA Diagnostics Inc.), and eye tracking will be used at the School of Optometry, University of Montreal. There is indeed a remodeling of the retina and oculomotor changes in Parkinson's Disease (PD) and these non-invasive techniques, which have been accepted for several years, will be used in patients in support of their clinical diagnosis compared to normal subjects.

Primary outcome measures

  • Lognormal primitives [Time frame: Day 1]
Secondary outcome measures (3)
  • Optical Coherence Tomography measures [Time frame: Day 1]
  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale section III [Time frame: Day 1]
  • Radboud Oral Motor Inventory for Parkinson's Disease [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Being diagnosed with Parkinsonism including idiopathic Parkinson's disease or a related syndrome;
  • Have motor symptoms of Parkinsonism for 6 years or less;
  • Be a healthy volunteer subject in good general health with no prior neurological history;
  • Age between 50-75 years old;
  • If applicable, be able to safely leave home in the morning without having taken antiparkinsonian medication for the past 12 hours.

Exclusion criteria

  • Major neurocognitive disorders;
  • History of other neurological conditions, such as ischemic or hemorrhagic stroke, paralysis of a limb, traumatic brain injury, epilepsy, orofacial dystonia, essential tremor;
  • History of oromandibular or laryngeal procedures;
  • Uncorrected deafness;
  • Any contraindication to pupillary dilation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • CHUM/Université de Montréal — Montreal

Publications

  • Spund B, Ding Y, Liu T, Selesnick I, Glazman S, Shrier EM, Bodis-Wollner I. Remodeling of the fovea in Parkinson disease. J Neural Transm (Vienna). 2013 May;120(5):745-53. doi: 10.1007/s00702-012-0909-5. Epub 2012 Dec 23. PMID 23263598
  • Jimenez B, Ascaso FJ, Cristobal JA, Lopez del Val J. Development of a prediction formula of Parkinson disease severity by optical coherence tomography. Mov Disord. 2014 Jan;29(1):68-74. doi: 10.1002/mds.25747. Epub 2013 Nov 14. PMID 24458320

Identifiers

NCT: NCT06161636 · 18.259

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗