A new healthcare service model using technology for diagnosing and monitoring Parkinson's disease

A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Objective (Early) Diagnosis and Therapeutic Monitoring of Parkinson's Disease Promoting Continuity of Care

This study is testing a new technology that uses wearable devices to see how well it can help diagnose and monitor Parkinson's disease in both healthy people and those with the condition.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna (other)
• Locations: 5 sites (Bagno a Ripoli, Firenze and 4 other locations)
• Trial ID: NCT06907589 on ClinicalTrials.gov

What this trial studies

This study utilizes the SensMode System, which includes wearable devices for analyzing upper and lower limb movements, to gather data from healthy individuals and patients with Parkinson's disease. The goal is to establish normative data for motor measures and enhance understanding of how this technology can aid in the early diagnosis and management of Parkinson's disease. Participants will include healthy adults and those with varying degrees of Parkinson's symptoms, allowing for a comprehensive analysis of motor function. The study aims to promote continuity of care through innovative technological solutions.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 50-80 and patients with Parkinson's disease who are not experiencing significant motor fluctuations.

Not a fit: Patients with severe motor fluctuations or significant neurological diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier diagnosis and better management of Parkinson's disease, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using wearable technology for monitoring Parkinson's disease, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Healthy subjects - Inclusion Criteria:

   * Adult subjects, both sexes, aged 50-80 years old
   * MMSE score \>= 24 absence of olfactory deficit detected on IOIT olfactory test (22). Age class 50-59 years: normal with score \<=5; age class 60-69 years: normal with score \<=6; age class \> 70 years: normal with score \<=7
   * absence of neurological diseases
   * absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine
   * expression of informed consent to participate in the study
2. Subjects with Parkinson's disease -- Inclusion criteria:

   * adult subjects, both sexes, 50-80 years of age
   * MMSE score \>= 24
   * subjects with Parkinson's disease in the absence of motor fluctuations and dyskinesias, or subjects with Parkinson's disease with mild motor fluctuations throughout the day, but to be examined in the ON phase and in the absence of dyskinesias
   * Hoehn and Yahr stage 1, 2, 3
   * absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine
   * expression of informed consent to participate in the study

Exclusion Criteria:

1. Healthy subjects - Exclusion criteria:

   * denial of informed consent to participate in the study
   * Presence of olfactory deficit detected on IOIT olfactory test. Age class 50-59 years: hyposmia with score \>=6; age class 60-69 years: hyposmia with score \>=7; age class \> 70 years: hyposmia with score \>=8
   * body weight greater than 120 kg
   * insufficient degree of cooperation
   * malignant neoplasm in progress or with negative follow-up of less than 6 years
   * structured joint stiffness in the upper and/or lower extremities preventing proper execution of movements
   * paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury
   * mono/multi/poly sensory and/or motor neuropathy
   * chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
   * vertiginous syndromes in the acute phase
   * neurodegenerative diseases
   * fever
   * venous thrombosis
   * cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
   * spinal or joint pain of various etiologies that may affect the performance of motor exercises
   * positive history of recurrent acute cervico-brachialgia and/or lumbosciatica
2. Subjects with Parkinson's disease - Exclusion criteria:

   * Denial of informed consent to participate in the study
   * Hoenn and Yahr stage 4, 5
   * Patient who needs to use an aid (cane or walker) while walking or cannot walk unless aided by a person
   * body weight greater than 120 kg
   * insufficient degree of cooperation
   * malignant neoplasm in place or with negative follow-up of less than 6 years
   * structured joint stiffness in the upper and/or lower extremities that prevents proper execution of movements
   * paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury mono/multi/poly sensory and/or motor neuropathy
   * chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
   * vertiginous syndromes in the acute phase
   * neurodegenerative diseases, excluding Parkinson's disease
   * fever
   * venous thrombosis
   * cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
   * spinal or joint pain of various etiologies that may affect the performance of motor exercises
   * positive history of recurrent acute cervico-brachialgia and/or low back pain

Where this trial is running

Bagno a Ripoli, Firenze and 4 other locations

• Ospedale Santa Maria Annunziata AUSL Toscana Centro — Bagno a Ripoli, Firenze, Italy (RECRUITING)
• Azienda Ospedaliero Universitaria Careggi — Florence, Italy (RECRUITING)
• IRCCS Fondazione Don Carlo Gnocchi Firenze — Florence, Italy (RECRUITING)
• Ospedale Apuane AUSL Toscana Nord Ovest — Massa, Italy (RECRUITING)
• IRCCS Istituto Auxologico Italiano, Ospedale San Luca — Milan, Italy (RECRUITING)

Study contacts

• Study coordinator: Filippo Cavallo

Conditions: Parkinson Disease, Healthy Adult, parkinson&amp, #39, s disease, wearable sensors, motor data