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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Parkinson Disease; Parkinsonian Syndromes

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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Pierre Blanchet, MD; Phone Number: 514-890-8123; Email: pierre.j.blanchet@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • Recruiting
      • CHUM/Université de Montréal
      • Contact: Pierre Blanchet, MD; Phone Number: 514-890-8000; Email: pierre.j.blanchet@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients with Parkinson Disease (PD); Participants will then have to perform three blocks of tests: the first focused on the scripted motor signature, a second on the voice signature, and a complementary block aimed at capturing the motor signature using gestures of greater amplitude. All the tests were designed to allow the characterization of the motor signature according to different aspects of motor control, but also to reproduce the same concepts in the three fields (scripted signature, voice signature and large amplitude motor signature), while allowing an acquisition of an approximate total duration of 30 minutes. For retinal photos, the subject's pupils will be dilated using eye drops (1% tropicamide and 2.5% phenylephrine) 15-20 minutes before taking the measurement. These drugs are considered the standard used by optometrists and ophthalmologists during pupil dilation.
Patients with atypical Parkinsonian Syndromes (PS); Participants will then have to perform three blocks of tests: the first focused on the scripted motor signature, a second on the voice signature, and a complementary block aimed at capturing the motor signature using gestures of greater amplitude. All the tests were designed to allow the characterization of the motor signature according to different aspects of motor control, but also to reproduce the same concepts in the three fields (scripted signature, voice signature and large amplitude motor signature), while allowing an acquisition of an approximate total duration of 30 minutes. For retinal photos, the subject's pupils will be dilated using eye drops (1% tropicamide and 2.5% phenylephrine) 15-20 minutes before taking the measurement. These drugs are considered the standard used by optometrists and ophthalmologists during pupil dilation.
Healthy volunteers; Participants will then have to perform three blocks of tests: the first focused on the scripted motor signature, a second on the voice signature, and a complementary block aimed at capturing the motor signature using gestures of greater amplitude. All the tests were designed to allow the characterization of the motor signature according to different aspects of motor control, but also to reproduce the same concepts in the three fields (scripted signature, voice signature and large amplitude motor signature), while allowing an acquisition of an approximate total duration of 30 minutes. For retinal photos, the subject's pupils will be dilated using eye drops (1% tropicamide and 2.5% phenylephrine) 15-20 minutes before taking the measurement. These drugs are considered the standard used by optometrists and ophthalmologists during pupil dilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lognormal primitives	Velocity profiles generated for simple movements (strokes) and certain vocal frequencies (formants), transformed to fit into the lognormal model	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical Coherence Tomography measures	Measures of thickness for macula, fovea, peripapillary retinal nerve fiber layer, divided in quadrants, expressed in microns.	Day 1
Movement Disorder Society-Unified Parkinson's Disease Rating Scale section III	Motor rating in the practically defined unmedicated state, in points	Day 1
Radboud Oral Motor Inventory for Parkinson's Disease	Clinical tool to evaluate perceived problems with speech, swallowing, and saliva in subjects with parkinsonism, in points	Day 1

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Optina Diagnostics Inc.
• Investigators: Principal Investigator: Pierre Blanchet, CHUM/Université de Montréal

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: 18.259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No