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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05355480
Other study ID # NEUR_04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date December 31, 2023

Study information

Verified date March 2023
Source Neuromed IRCCS
Contact Antonio Suppa, MD
Phone +00390649914074
Email antonio.suppa@uniroma1.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Healthy conditions - clinical diagnosis of Parkinson's disease Exclusion Criteria: - cognitive decline

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Neuromed Pozzilli

Sponsors (1)

Lead Sponsor Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stroke size of handwriting characters height of single letters through study completion, an average of 1 year
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