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NCT Number: NCT06378619

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

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.

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Key information

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf

Barcelona, Catalonia, 08810, Spain

Location status: Recruiting

Location contact

José Luis Camacho, MD

CONTACT

[email protected]

+34 938960025

José Luis Camacho, MD

PRINCIPAL_INVESTIGATOR

Noemí Casaponsa

CONTACT

[email protected]

+34 938960025 ext. 43197

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Sensitivity

    Time frame: through study completion, an average of 1 year

    Proportion of participants with confirmed Parkinson's disease for whom the machine learning-based diagnostic algorithm yields a 'positive' result.

  2. Specificity

    Time frame: through study completion, an average of 1 year

    Proportion of participants with confirmed essential tremor for whom the machine learning-based diagnostic algorithm yields a 'negative' result.

Secondary outcomes

  1. Reliability

    Time frame: through study completion, an average of 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

José Luis Camacho, MD

CONTACT

[email protected]

+34 938960025

Noemí Casaponsa

CONTACT

[email protected]

+34 938960025 ext. 43197

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Official study title

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

Acronym: MATSEP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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