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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential Tremor | Tris group will include 55 participants affected by essential tremor |
| |
| Parkinson Disease | Tris group will include 55 participants affected by Parkinson Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Proportion of participants with confirmed Parkinson's disease for whom the machine learning-based diagnostic algorithm yields a 'positive' result. | 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 1 year |
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Inclusion Criteria:
Group 1:
Group 2:
Exclusion Criteria:
Alcoholism of sufficient intensity to influence handwriting or cause neuropathy, at the investigator's discretion. Peripheral neuropathy of any cause. Dystonias. Previous stroke.
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The participants will be contacted based on the patient registry with follow-up in the neurology clinic of the study center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Luis Camacho, MD | Contact | +34 938960025 | jlcamacho@csapg.cat | |
| Noemí Casaponsa | Contact | +34 938960025 | 43197 | recerca@csapg.cat |
| Name | Affiliation | Role |
|---|---|---|
| José Luis Camacho, MD | Consorsi Sanitari Alt Penedes i Garraf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf | Recruiting | Barcelona | Catalonia | 08810 | Spain |
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).
After publication of main results of the study.
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.
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| ID | Term |
|---|---|
| D014202 | Tremor |
| D020329 | Essential Tremor |
| D010300 | Parkinson Disease |
| D004194 | Disease |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| 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. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010335 | Pathologic Processes |