- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05355480
Handwriting Analysis in Movement Disorders (HANDWRML)
March 21, 2023 updated by: Antonio Suppa, Neuromed IRCCS
Advanced Machine Learning Analysis of Handwriting in Patients With Movement Disorders
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Antonio Suppa, MD
- Phone Number: +00390649914074
- Email: antonio.suppa@uniroma1.it
Study Locations
-
-
-
Pozzilli, Italy, 86077
- Recruiting
- IRCCS Neuromed
-
Contact:
- Antonio Suppa, MD
- Phone Number: +00390649914074
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects and patients with idiopathic PD
Description
Inclusion Criteria:
- Healthy conditions
- clinical diagnosis of Parkinson's disease
Exclusion Criteria:
- cognitive decline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Healthy Subjects
Collection of handwriting samples
|
Patients with Parkinson's disease
Collection of handwriting samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke size of handwriting characters
Time Frame: through study completion, an average of 1 year
|
height of single letters
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
April 20, 2022
First Submitted That Met QC Criteria
April 29, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUR_04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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