Clinical trial NCT06378619: Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach
Official title: Machine Learning Analysis Of The Tapping Test And The Archimedean Spiral For The Differential Diagnosis Of Essential Tremor And Parkinson's Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tremor
Essential Tremor
Parkinson Disease
Keywords: Tremor
Essential Tremor
Parkinson Disease
Diagnosis, Differential
Machine Learning
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 110
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

Primary outcomes:
measure: Sensitivity
timeFrame: through study completion, an average of 1 year
measure: Specificity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Reliability
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf
state: Cataluña
Study officials:
affiliation: Consorsi Sanitari Alt Penedes i Garraf
name: José Luis Camacho, MD
role: PRINCIPAL_INVESTIGATOR
References: