Primary ParkinsonismCoMDA-ML-PNCT04858893
Application of Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms
An observational study of Primary Parkinsonism and Secondary Vascular Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Parkinsonism, Secondary Vascular Parkinson Disease, Multiple System Atrophy
- What is being tested?
- CoMDA associated with Neural Net 91 classificator
- How many people
- 562 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 500 subjects suffering from different forms of Parkinson Disease or Atypical Parkinsonims Syndorme and 61 Helathy Controls
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Parkinsonism, Secondary Vascular Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
- Being tested
- CoMDA associated with Neural Net 91 classificator
- Medical subject headings
- Parkinson Disease, Parkinson Disease, Secondary, Multiple System Atrophy, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoMDA associated with Neural Net 91 classificatorDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: CoMDA associated with Neural Net 91 classificator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Net 91 classificator from CoMDA score
prediction of cognitive level obtained from the application of Neural Net 91 classificator at CoMDA score
Measured: 30 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jan 2017
- Primary completion1 Feb 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale di Vipiteno-Sterzing (SABES-ASDAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858893
- Sponsor's protocol ID
- CoMDA
- Acronym
- CoMDA-ML-P
- Status last verified
- May 2021
- First submitted
- 21 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35410449
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Screening in Patients With Parkinsonism: Proposal for a New, Machine Learning Based Diagnostic Tool
- ClinicalTrials.gov ID
- NCT04858893
- Acronym / sponsor ID
- CoMDA-ML-P / CoMDA
- Conditions
- Primary Parkinsonism, Secondary Vascular Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Collaborators
- Ospedale di Vipiteno-Sterzing (SABES-ASDAA)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects affected from Parkinsonims | – | Diagnostic Test: CoMDA associated with Neural Net 91 classificatorScores of MMSE, FAB MoCA were summarized to calculate the CoMDA scores, than they were used to develop the Neural Net 91 classificator |
| Health Controls | – | Diagnostic Test: CoMDA associated with Neural Net 91 classificatorCoMDA was administered and total score was calculate to develop the Neural Net 91 classificator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 subjects suffering from different forms of Parkinson Disease or Atypical Parkinsonims Syndorme and 61 Helathy Controls
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoMDA associated with Neural Net 91 classificator | Diagnostic test | Health Controls, Subjects affected from Parkinsonims |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Derived from this study: PubMed 35410449Ortelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Parkinsonism and Secondary Vascular Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural Net 91 classificator from CoMDA score (time frame: 30 minuts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.