A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Obj… (NCT06907589) | Clinical Trial Compass
RecruitingNot Applicable
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
Italy250 participantsStarted 2024-05-13
Plain-language summary
The present study aims to use the SensMode System - a system composed of wearable devices for upper and lower limb movement analysis and electronic device for data acquisition and processing - on healthy subjects, subjects with idiopathic hyposmia, patients with Parkinson's disease, and subjects with de-novo drug-naïve extrapyramidal syndrome. The purpose is to identify normative data of objective motor measures obtained with such a system, as well as to increase knowledge about the potential contribution such a solution can make to the preclinical diagnosis of Parkinson's disease and the management of patients with this disease.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy subjects - Inclusion Criteria:
. Subjects with Parkinson's disease -- Inclusion criteria:
Exclusion criteria
. Healthy subjects - Exclusion criteria:
. Subjects with Parkinson's disease - Exclusion criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be testing a technology-based monitoring system for Parkinson's — things like measuring how many times I can repeat a movement and analyzing my walking patterns with a device — so can you explain what kinds of tests or wearable sensors would actually be involved, and whether the physical demands of repeated movement tasks are appropriate given my current condition?
2Since this trial is listed as Phase NA, which often means it's focused on testing a diagnostic or monitoring tool rather than a treatment drug, can you help me understand whether participating would change my actual care in any way, or is it purely about collecting data to validate the technology?
3The trial is currently recruiting both people with Parkinson's and healthy adults — does my specific stage or symptom profile make me a good fit to discuss with the research team, or would standard clinical monitoring serve me just as well right now?
4The study appears to measure very detailed movement signals like gait timing, rotation speed, and accelerometer frequencies — how would that data be used, and would my doctor have access to the results in a way that could actually inform my treatment going forward?
5Given that this is focused on early diagnosis and ongoing monitoring rather than a new drug or therapy, is there any risk to participating, and could being part of this study delay or interfere with starting other treatments I might need?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of repetitions
Timeframe: at Enrollment (T0)
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Number of repetitions
Timeframe: at Enrollment (T0)
3
Number of repetitions
Timeframe: at Enrollment (T0)
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Number of repetitions
Timeframe: at Enrollment (T0)
5
Number of repetitions
Timeframe: at Enrollment (T0)
6
Number of repetitions
Timeframe: at Enrollment (T0)
7
Number of repetitions
Timeframe: at Enrollment (T0)
8
Number of repetitions
Timeframe: at Enrollment (T0)
Trial details
NCT IDNCT06907589
SponsorScuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna