Application od Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms

Brief Title

Application of Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms

Official Title

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

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.
    

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

Primary Outcome

Neural Net 91 classificator from CoMDA score

Condition

Primary Parkinsonism

Intervention

CoMDA associated with Neural Net 91 classificator

Study Arms / Comparison Groups

 Subjects affected from Parkinsonims

Description:  Scores of MMSE, FAB MoCA were summarized to calculate the CoMDA scores, than they were used to develop the Neural Net 91 classificator

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

562

Start Date

January 1, 2017

Completion Date

August 31, 2020

Primary Completion Date

February 1, 2020

Eligibility 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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Italy

Location Countries

Italy

NCT ID

NCT04858893

Organization ID

CoMDA

Responsible Party

Sponsor

Study Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Collaborators

 Ospedale di Vipiteno-Sterzing (SABES-ASDAA)

Study Sponsor

, , 

Verification Date

May 2021