NCT05355480

Brief Summary

Handwriting is a complex cognitive prowess that deteriorates in patients affected by neurodegenerative diseases, including movement disorders. More in detail, patients with Parkinson's disease (PD) may manifest prominent handwriting abnormalities which have been collectively identified as parkinsonian micrographia. MIcrographia may manifest at the onset of the disease and then worsens progressively with time. Previous techniques released to investigate micrographia in PD relied on perceptual analysis of simple tasks or were based on expensive technological tools, including tablets. However, handwriting can be promptly collected in an ecological scenario, through safe, cheap, and largely available tools. Also, the objective handwriting analysis through artificial intelligence would represent an innovative strategy even superior to previous techniques, since it allows for the analysis of large amounts of data. In this experimental project, the investigators apply a specific machine learning algorithm to analyze handwriting samples recorded in healthy controls and PD patients. The study aims to verify whether the technique proposed by the investigators would be able to detect parkinsonian micrographia objectively, monitor the evolution of handwriting abnormalities and assess the symptomatic improvement of handwriting following L-Dopa administration in PD patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

April 20, 2022

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stroke size of handwriting characters

    height of single letters

    through study completion, an average of 1 year

Study Arms (2)

Healthy Subjects

Collection of handwriting samples

Patients with Parkinson's disease

Collection of handwriting samples

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects and patients with idiopathic PD

You may qualify if:

  • Healthy conditions
  • clinical diagnosis of Parkinson's disease

You may not qualify if:

  • cognitive decline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Neuromed

Pozzilli, 86077, Italy

RECRUITING

MeSH Terms

Conditions

Movement DisordersParkinson Disease

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 2, 2022

Study Start

December 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations