CClinicalTrials.gg
RecruitingNCT06161636Updated Feb 14, 2025

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

An observational study in Parkinson Disease, Healthy and Parkinsonian Syndromes, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational

From the registry’s dates

  • Started Feb 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Healthy
  • Parkinsonian Syndromes
03

In context

Parkinson Disease

4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.

This study's planned enrollment of 90 is close to the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Lognormal primitives

    Velocity profiles generated for simple movements (strokes) and certain vocal frequencies (formants), transformed to fit into the lognormal model

    Time frame: Day 1

Secondary outcomes

  1. Optical Coherence Tomography measures

    Measures of thickness for macula, fovea, peripapillary retinal nerve fiber layer, divided in quadrants, expressed in microns.

    Time frame: Day 1

  2. Movement Disorder Society-Unified Parkinson's Disease Rating Scale section III

    Motor rating in the practically defined unmedicated state, in points

    Time frame: Day 1

  3. 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

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • CHUM/Université de Montréal
    Montréal, Quebec H2X 0A9, Canada
    Recruiting
08

References and documents

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. PubMed 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. PubMed 24458320 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06161636
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Optina Diagnostics Inc.
Responsible party
Sponsor
First posted
Dec 8, 2023
Start date
Feb 19, 2020
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Feb 14, 2025

Study contacts

Pierre Blanchet, MD
Contact
pierre.j.blanchet@umontreal.ca
514-890-8123
Pierre Blanchet
principal investigator · CHUM/Université de Montréal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion