TremorMATSEPNCT06378619
Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach
An observational study of Tremor and Essential Tremor, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Tremor, Essential Tremor, Parkinson Disease
- What is being tested?
- Tapping Test and Archimedes Spiral
- Type of treatment
- Pill or oral medicine
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be contacted based on the patient registry with follow-up in the neurology clinic of the study center.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf
Barcelona, Catalonia, 08810
About this study
Official title: 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.
- Conditions
- Tremor, Essential Tremor, Parkinson Disease
- Being tested
- Tapping Test, Archimedes Spiral
- Keywords
- Tremor, Essential Tremor, Parkinson Disease, Diagnosis, Differential, Machine Learning
- Medical subject headings
- Tremor, Essential Tremor, Parkinson Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapping TestDiagnostic 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 SpiralDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Essential Tremor | Tris group will include 55 participants affected by essential tremor Receives: Diagnostic Test: Tapping Test; Diagnostic Test: Archimedes Spiral | |
| Parkinson Disease | Tris group will include 55 participants affected by Parkinson Disease Receives: Diagnostic Test: Tapping Test; Diagnostic Test: Archimedes Spiral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Proportion of participants with confirmed Parkinson's disease for whom the machine learning-based diagnostic algorithm yields a 'positive' result.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 Jul 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Luis Camacho, MD, Principal investigator, Consorsi Sanitari Alt Penedes i Garraf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378619
- Sponsor's protocol ID
- CSAPG-50
- Acronym
- MATSEP
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Analysis Of The Tapping Test And The Archimedean Spiral For The Differential Diagnosis Of Essential Tremor And Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06378619
- Acronym / sponsor ID
- MATSEP / CSAPG-50
- Conditions
- Tremor, Essential Tremor, Parkinson Disease
- Keywords
- Tremor, Essential Tremor, Parkinson Disease, Diagnosis, Differential, Machine Learning
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential Tremor | – | Diagnostic Test: Tapping Test, Diagnostic Test: Archimedes SpiralTris group will include 55 participants affected by essential tremor |
| Parkinson Disease | – | Diagnostic Test: Tapping Test, Diagnostic Test: Archimedes SpiralTris group will include 55 participants affected by Parkinson Disease |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be contacted based on the patient registry with follow-up in the neurology clinic of the study center.
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapping TestFor 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 | Essential Tremor, Parkinson Disease |
| Archimedes SpiralFor 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. | Diagnostic test | Essential Tremor, Parkinson Disease |
Primary outcome
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.
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.
1 secondary outcome
Reliability
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luis Camacho, MD principal investigator
Consorsi Sanitari Alt Penedes i Garraf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tremor and Essential Tremor, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.