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

NCT06161636 | Recruiting

• 1 other identifier: 18.259
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Healthy; Parkinsonian Syndromes

Outcome Measures

Primary Outcomes (1)

• Lognormal primitives

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

  Day 1

Secondary Outcomes (3)

• Optical Coherence Tomography measures

  Day 1

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

  Day 1

• Radboud Oral Motor Inventory for Parkinson's Disease

  Day 1

Study Arms (3)

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.

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Optina Diagnostics Inc.: collaborator

Study Sites (1)

CHUM/Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 23263598 BACKGROUND

• 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.

  PMID: 24458320 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Pierre Blanchet

  CHUM/Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Blanchet, MD

CONTACT

514-890-8123; pierre.j.blanchet@umontreal.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: December 8, 2023
• Study Start: February 19, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)