Clinical trial NCT06161636: Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease
Official title: Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Healthy
Parkinsonian Syndromes
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Optina Diagnostics Inc.
First posted: 2023-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sixty patients with Parkinson's disease (PD; N=30) or atypical Parkinsonian Syndromes (PS; N=30) will be recruited within the first 6 years of the disease. They will be recruited at the CHUM or from the Quebec Parkinson Network, and compared to healthy volunteers of comparable age (N=30). The atypical PS group will include people with multiple system atrophy or progressive supranuclear palsy. The probable final diagnosis of the two groups of patients will be confirmed by telephone contact two years after the research visit.

Brief summary: 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.

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.

Primary outcomes:
measure: Lognormal primitives
timeFrame: Day 1
Secondary outcomes:
measure: Optical Coherence Tomography measures
timeFrame: Day 1
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale section III
timeFrame: Day 1
measure: Radboud Oral Motor Inventory for Parkinson's Disease
timeFrame: Day 1
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM/Université de Montréal
state: Quebec
Study officials:
affiliation: CHUM/Université de Montréal
name: Pierre Blanchet
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.