Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach

Parkinson Disease Clinical Trial

— MATSEP  

Official title:

Machine Learning Analysis Of The Tapping Test And The Archimedean Spiral For The Differential Diagnosis Of Essential Tremor And Parkinson's Disease.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378619
• Other study ID #: CSAPG-50
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: José Luis Camacho, MD
• Phone: +34 938960025
• Email: jlcamacho[@]csapg.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

Inclusion Criteria:

• Possibility to collaborate in the necessary evaluations.

• Follow-up in the specialized consultation of Movement Disorders at the Neurology Service of Hospital Sant Camil-Consorci Sanitari Alt Penedes i Garraf.

• Legal capacity to provide informed consent.

• Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.

• Participant with criteria from Group 1 or 2:

Group 1:

• Confirmed diagnosis of tremor due to Parkinson's disease, clinically established, based on the diagnostic criteria of the Movement Disorders Society, and additionally:

• Tremor associated with bradykinesia of any duration.

• Confirmatory clinical diagnosis of tremor due to Parkinson's disease (stages 1 to 2 of Hoehn and Yahr) by the neurologist responsible for the participant's follow-up.

Group 2:

• Confirmed diagnosis of essential tremor, based on the criteria of the Movement Disorders Society, and additionally:

• Positional tremor plus kinetic and/or resting tremor with follow-up in outpatient neurology consultations for at least 3 years without a change in diagnosis.

• Absence of bradykinesia.

Exclusion Criteria:

• Patients undergoing treatment with antipsychotics or antidepressants.

• Patients with Parkinson's disease and dyskinesias.

• Patients undergoing treatment with dopaminergic agonists or primidone.

• Tremor of such severity that it prevents continuous tracing, at the investigator's discretion.

• Cognitive or affective pathology that limits the ability to collaborate with the study procedures.

• Participation in another clinical study involving an intervention, procedure, or visit frequency that is incompatible with the present study.

• Participants diagnosed with any of the following conditions:

Alcoholism of sufficient intensity to influence handwriting or cause neuropathy, at the investigator's discretion. Peripheral neuropathy of any cause. Dystonias. Previous stroke.

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Tremor

Intervention

Diagnostic Test:
• Tapping Test
For the administration of the tapping test, a computer application installed on a Tablet will be used. The test will be administered up to 3 times, with a 15-minute interval between each administration. Each tapping test trial will last 15 seconds. At the beginning of the session, the patient will perform 2 practice attempts.
• Archimedes Spiral
For the administration of the Archimedean spiral, a computer application installed on a Tablet will be used. The Tablet screen will display a drawing of the spiral, serving as a reference for the participant. The test will be administered up to 3 times, with a 15-minute interval between each administration. At the beginning of the session, the patient will perform 2 practice attempts.

Locations

Country	Name	City	State
Spain	Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Proportion of participants with confirmed Parkinson's disease for whom the machine learning-based diagnostic algorithm yields a 'positive' result.	through study completion, an average of 1 year
Primary	Specificity	Proportion of participants with confirmed essential tremor for whom the machine learning-based diagnostic algorithm yields a 'negative' result.	through study completion, an average of 1 year
Secondary	Reliability	The reliability of the diagnostic algorithm will be evaluated based on the repeatability of the classification result (positive or negative) among the different tests conducted on the same patient	through study completion, an average of 1 year