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

NCT06378619 | Recruiting

• 1 other identifier: CSAPG-50
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Tremor; Essential Tremor; Parkinson Disease; Diagnosis, Differential; Machine Learning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Reliability

  through study completion, an average of 1 year

Study Arms (2)

Essential Tremor

Tris group will include 55 participants affected by essential tremor

Diagnostic Test: Tapping Test; Diagnostic Test: Archimedes Spiral

Parkinson Disease

Tris group will include 55 participants affected by Parkinson Disease

Diagnostic Test: Tapping Test; Diagnostic Test: Archimedes Spiral

Interventions

Tapping Test 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.

Essential Tremor; Parkinson Disease

Archimedes Spiral 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.

Essential Tremor; Parkinson Disease

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf

Barcelona, Catalonia, 08810, Spain

RECRUITING

MeSH Terms

Conditions

Tremor; Essential Tremor; Parkinson Disease; Disease

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes

Study Officials

• José Luis Camacho, MD

  Consorsi Sanitari Alt Penedes i Garraf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Luis Camacho, MD

CONTACT

+34 938960025; jlcamacho@csapg.cat

Noemí Casaponsa

CONTACT

+34 938960025; recerca@csapg.cat

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 22, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• 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.

Locations

ES (1)