ClinicalTrials.gg
TerminatedNCT06378619MATSEPUpdated Oct 28, 2026

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

An observational study in Tremor, Essential Tremor and Parkinson Disease, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Terminated at 1 site in Spain. Open to participants aged 45 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Observational

Why this study was terminated
Poor recruitment
Updated Oct 28, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
11
Ages
45 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tremor
  • Essential Tremor
  • Parkinson Disease

Keywords

  • Tremor
  • Essential Tremor
  • Parkinson Disease
  • Diagnosis, Differential
  • Machine Learning
03

In context

Tremor

158 studies on the registry are indexed under Tremor; 44 are open to participants now.

This study's enrollment of 11 is below the median of 74 across 45 observational studies indexed under Tremor.

Browse Tremor studies →

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 41 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 79 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testTapping 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 testArchimedes 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.

06

What researchers measure

Primary outcomes

  1. Sensitivity

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

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

  2. Specificity

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

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

Secondary outcomes

  1. 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

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

07

Study locations

1 site
  • Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf
    Barcelona, Catalonia 08810, Spain
08

References and documents

Individual participant data

Plan to share: Yes — 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).

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Jul 2024 to primary completion in Mar 2026, 19 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 28, 2026: primary completion Jul 2026 → Mar 2026 and completion Jul 2026 → Mar 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2024
First posted
Apr 22, 2024
StartActual
Jul 15, 2024
Primary completionActual
Mar 1, 2026was Jul 2026
CompletionActual
Mar 1, 2026was Jul 2026
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Terminated Poor recruitment
changed Oct 28, 2026
Primary completion
Jul 2026→Mar 1, 2026 (actual)
Oct 28, 2026
Study completion
Jul 2026→Mar 1, 2026 (actual)
Oct 28, 2026
Enrollment
110 (estimated)→11 (actual)
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Recruiting→Terminated
    Why stopped Poor recruitment
    Primary completion Jul 2026→Mar 1, 2026 (now actual)
    Study completion Jul 2026→Mar 1, 2026 (now actual)
    Enrollment 110 (estimated)→11 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06378619
Lead sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Jul 15, 2024
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026
Last update
Oct 28, 2026

Study contacts

José Luis Camacho, MD
principal investigator · Consorsi Sanitari Alt Penedes i Garraf

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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