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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Essential Tremor; Tremor
• Intervention / Treatment: Diagnostic test: Tapping Test; Diagnostic test: Archimedes Spiral

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
• Study Contact Backup: Name: José Luis Camacho, MD; Phone Number: +34 938960025; Email: jlcamacho@csapg.cat

Study Locations

• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08810
      • Recruiting
      • Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf
      • Contact: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
      • Contact: José Luis Camacho, MD; Phone Number: +34 938960025; Email: jlcamacho@csapg.cat
      • Principal Investigator: José Luis Camacho, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The participants will be contacted based on the patient registry with follow-up in the neurology clinic of the study center.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Essential Tremor; Tris group will include 55 participants affected by essential tremor	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.; Diagnostic test: 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.
Parkinson Disease; Tris group will include 55 participants affected by Parkinson Disease	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.; Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: José Luis Camacho, MD, Consorsi Sanitari Alt Penedes i Garraf

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Parkinson Disease; Essential Tremor; Tremor; Machine Learning; Diagnosis, Differential
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Dyskinesias; Parkinson Disease; Tremor; Essential Tremor
• Other Study ID Numbers: CSAPG-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No