NCT06378619 Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach
| NCT ID | NCT06378619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf |
| Condition | Tremor |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2024-07-15 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
José Luis Camacho, MD
PRINCIPAL INVESTIGATOR
Consorsi Sanitari Alt Penedes i Garraf
Frequently Asked Questions
Who can join the NCT06378619 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 79 Years, studying Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06378619 currently recruiting?
Yes, NCT06378619 is actively recruiting participants. Contact the research team at jlcamacho@csapg.cat for enrollment information.
Where is the NCT06378619 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06378619 clinical trial?
NCT06378619 is sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. The principal investigator is José Luis Camacho, MD at Consorsi Sanitari Alt Penedes i Garraf. The trial plans to enroll 110 participants.