Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT07189468
Eligibility Criteria:
Inclusion Criteria:
* Parkinson's disease diagnosis according to MDS criteria (Postuma et al., 2015)
* Disease duration ranging from 5 to 10 years
* Age 40-80
* Patients in stages 2 and 3 of the Hoehn and Yahr (a functional disability scale) in the ON condition
* The participant is using a compatible smartphone
* Written informed consent
Exclusion Criteria:
* Atypical Parkinsonian Syndrome
* Second-line device-aided treatments
* Patients with \>4 daily doses of L-DOPA
* Daily levodopa equivalent dose \> 1500 mg
* Ongoing hallucinations requiring short-term treatment adjustment
* Inability to provide informed consent or participate in the study
* Inability to use the smartwatch and/or the mAI-Care app - as judged by investigator
* Lacking motivation to participate in study procedures - as judged by investigator
* Under adult autonomy protection system, legal guardianship or incapacitation
* Pregnant and breast-feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT07189468
Study Brief:
Protocol Section:
NCT07189468