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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT04459559
Eligibility Criteria:
Inclusion Criteria:
* Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.
* Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.
* MoCA ≥ 22/30.
* Participant has signed the informed consent.
Exclusion Criteria:
* Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).
* Significantly, impaired cognitive skills render the participant unable to use the TCD.
* Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.
* Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04459559
Study Brief:
Protocol Section:
NCT04459559