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

Cognitive Screening in Patients With Parkinsonism: Proposal for a New, Machine Learning Based Diagnostic Tool

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.

Study Overview

• Status: Completed
• Conditions: Supranuclear Palsy, Progressive; Multiple System Atrophy; Primary Parkinsonism; Secondary Vascular Parkinson Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 562

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural Net 91 classificator from CoMDA score	prediction of cognitive level obtained from the application of Neural Net 91 classificator at CoMDA score	30 minuts

Collaborators and Investigators

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
• Collaborators: Ospedale di Vipiteno-Sterzing (SABES-ASDAA)

Publications and helpful links

General Publications

• Ortelli P, Ferrazzoli D, Versace V, Cian V, Zarucchi M, Gusmeroli A, Canesi M, Frazzitta G, Volpe D, Ricciardi L, Nardone R, Ruffini I, Saltuari L, Sebastianelli L, Baranzini D, Maestri R. Optimization of cognitive assessment in Parkinsonisms by applying artificial intelligence to a comprehensive screening test. NPJ Parkinsons Dis. 2022 Apr 11;8(1):42. doi: 10.1038/s41531-022-00304-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Autonomic Nervous System Diseases; Ocular Motility Disorders; Paralysis; Primary Dysautonomias; Hypotension; Ophthalmoplegia; Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Parkinson Disease, Secondary
• Other Study ID Numbers: CoMDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No