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NCT Number: NCT06161636

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHUM/Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location status: Recruiting

Location contact

Pierre Blanchet, MD

CONTACT

[email protected]

514-890-8000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Lognormal primitives

    Time frame: Day 1

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

Secondary outcomes

  1. Optical Coherence Tomography measures

    Time frame: Day 1

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

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

    Time frame: Day 1

    Motor rating in the practically defined unmedicated state, in points

  3. Radboud Oral Motor Inventory for Parkinson's Disease

    Time frame: Day 1

    Clinical tool to evaluate perceived problems with speech, swallowing, and saliva in subjects with parkinsonism, in points

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Blanchet, MD

CONTACT

[email protected]

514-890-8123

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Optina Diagnostics Inc.

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Dec 8, 2023
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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