Application of Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms (CoMDA-ML-P)

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ClinicalTrials.gov Identifier: NCT04858893

Recruitment Status : Completed

First Posted : April 26, 2021

Last Update Posted : May 12, 2021

Sponsor:

Collaborator:

Ospedale di Vipiteno-Sterzing (SABES-ASDAA)

Information provided by (Responsible Party):

Ospedale Generale Di Zona Moriggia-Pelascini

Study Description

Brief Summary:

Based on a prospectively collected data analysis, a new tool, namely CoMDA (Cognition in Movement Disorders Assessment) is developed by merging each item of Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Frontal Assessment Battery (FAB). A machine learning, able to classify the cognitive profile and predict patients' at risk of dementia, is created.

Condition or disease	Intervention/treatment
Primary Parkinsonism Secondary Vascular Parkinson Disease Multiple System Atrophy Supranuclear Palsy, Progressive	Diagnostic Test: CoMDA associated with Neural Net 91 classificator

Detailed Description:

A prospectively data-base was setting up, collecting CoMDA and in-depht-neuropsychologocal-battery scores, obtained from the evaluation of 500 patients with parkinsonisms. Data were analyzed to compare the classification of patient cognition profile, obtained with CoMDA, MMSE, MoC and FAB, with that obtained from in-depth neuropsychological evaluation. A very high percentage of false negative emerged, for MMSE, MoCA and FAB. Conversely, the CoMDA score significantly reduces the rate of false negative.

This new tool, namely "CoMDA" (Cognition in Movement Disorders Assessment), was composed, by merging each item of Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Frontal Assessment Battery (FAB). Moreover, we created a machine learning, namely "Neural Net 91classification" able to classify the cognitive profile and predict patients' at risk of dementia, providing a prediction of the findings resulting from a in-depht neuropsychological evaluation.

CoMDA and the related Neural Net 91classification represent a reliable, time-sparing screening instrument, which is much more powerful of other common, widely-adopted tools.

Study Design

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Study Type :	Observational
Actual Enrollment :	562 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Cognitive Screening in Patients With Parkinsonism: Proposal for a New, Machine Learning Based Diagnostic Tool
Actual Study Start Date :	January 1, 2017
Actual Primary Completion Date :	February 1, 2020
Actual Study Completion Date :	August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Perry syndrome Multiple system atrophy Progressive supranuclear palsy Parkinson disease

Genetic and Rare Diseases Information Center resources: Multiple System Atrophy Progressive Supranuclear Palsy

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Subjects affected from Parkinsonims Scores of MMSE, FAB MoCA were summarized to calculate the CoMDA scores, than they were used to develop the Neural Net 91 classificator	Diagnostic Test: CoMDA associated with Neural Net 91 classificator
Health Controls CoMDA was administered and total score was calculate to develop the Neural Net 91 classificator	Diagnostic Test: CoMDA associated with Neural Net 91 classificator

Outcome Measures

Primary Outcome Measures :

Neural Net 91 classificator from CoMDA score [ Time Frame: 30 minuts ]
prediction of cognitive level obtained from the application of Neural Net 91 classificator at CoMDA score

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

500 subjects suffering from different forms of Parkinson Disease or Atypical Parkinsonims Syndorme and 61 Helathy Controls

Criteria

Inclusion Criteria:

diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria (Postuma et al. 2015); b) diagnosis of PSP according to the MDS clinical diagnostic criteria (Höglinger et al. 2017); c) diagnosis of MSA according to the second diagnostic consensus statement (Gilman et al. 2008); d) diagnosis of VP according to Zijlmans et al (Zijlmans et al. 2004).

Exclusion Criteria:

a) any focal brain lesion detected with brain imaging studies (CT or MRI); b) diagnosis of clinically relevant psychiatric disorders, psychosis (evaluated with Neuropsychiatric Inventory) and/or delirium; c) diagnosis of dementia or MCI; d) diagnosis of neurological diseases other than PD or atypical parkinsonian syndromes; e) other medical conditions negatively affecting the cognitive status; f) disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III, such as to affect the psychometric evaluation; g) disturbing dyskinesia, corresponding to scores 2-4 in the specific items of MDS-UPDRS III, such as to affect the psychometric evaluation; h) auditory and/or visual dysfunctions impairing the patient´s ability to perform cognitive tests.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858893

Locations

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Italy
"Moriggia Pelascini" Hospital
Gravedona E Uniti, Como, Italy, 22015

Sponsors and Collaborators

Ospedale Generale Di Zona Moriggia-Pelascini

Ospedale di Vipiteno-Sterzing (SABES-ASDAA)

More Information

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Responsible Party:	Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier:	NCT04858893
Other Study ID Numbers:	CoMDA
First Posted:	April 26, 2021 Key Record Dates
Last Update Posted:	May 12, 2021
Last Verified:	May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Parkinson Disease Multiple System Atrophy Shy-Drager Syndrome Parkinsonian Disorders Supranuclear Palsy, Progressive Parkinson Disease, Secondary Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases	Primary Dysautonomias Autonomic Nervous System Diseases Hypotension Vascular Diseases Cardiovascular Diseases Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Paralysis Neurologic Manifestations Eye Diseases

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