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

NCT ID: NCT06161636

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2028-12-31

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.

Conditions

Parkinson Disease; Healthy; Parkinsonian Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Optina Diagnostics Inc.

INDUSTRY

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Blanchet

Role: PRINCIPAL_INVESTIGATOR

CHUM/Université de Montréal

Locations

CHUM/Université de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Pierre Blanchet, MD

Role: CONTACT

pierre.j.blanchet@umontreal.ca

514-890-8123

Facility Contacts

Pierre Blanchet, MD

Role: primary

pierre.j.blanchet@umontreal.ca

514-890-8000

References

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.

Reference Type: BACKGROUND

PMID: 23263598 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24458320 (View on PubMed)

Other Identifiers

18.259

Identifier Type: -

Identifier Source: org_study_id