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

NCT ID: NCT06378619

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Tremor; Essential Tremor; Parkinson Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Essential Tremor

Tris group will include 55 participants affected by essential tremor

Tapping Test

Intervention Type: DIAGNOSTIC_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

Intervention Type: DIAGNOSTIC_TEST

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

Tapping Test

Intervention Type: DIAGNOSTIC_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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Luis Camacho, MD

Role: PRINCIPAL_INVESTIGATOR

Consorsi Sanitari Alt Penedes i Garraf

Locations

Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

José Luis Camacho, MD

Role: CONTACT

jlcamacho@csapg.cat

+34 938960025

Noemí Casaponsa

Role: CONTACT

recerca@csapg.cat

+34 938960025 ext. 43197

Facility Contacts

José Luis Camacho, MD

Role: primary

jlcamacho@csapg.cat

+34 938960025

Noemí Casaponsa

Role: backup

recerca@csapg.cat

+34 938960025 ext. 43197

Other Identifiers

CSAPG-50

Identifier Type: -

Identifier Source: org_study_id