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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161636
• Other study ID #: 18.259
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Pierre Blanchet, MD
• Phone: 514-890-8123
• Email: pierre.j.blanchet[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonian Syndromes

Locations

Country	Name	City	State
Canada	CHUM/Université de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Optina Diagnostics Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lognormal primitives	Velocity profiles generated for simple movements (strokes) and certain vocal frequencies (formants), transformed to fit into the lognormal model	Day 1
Secondary	Optical Coherence Tomography measures	Measures of thickness for macula, fovea, peripapillary retinal nerve fiber layer, divided in quadrants, expressed in microns.	Day 1
Secondary	Movement Disorder Society-Unified Parkinson's Disease Rating Scale section III	Motor rating in the practically defined unmedicated state, in points	Day 1
Secondary	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