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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03741920
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to sign a written informed consent for study participation
* Age 46 - 83 years at the time of consent (per PKG Indications for Use, see Technical Instructions Manual)
* Responsive to dopaminergic medications
Exclusion Criteria:
* Contraindication to increasing dopaminergic therapy, such as current or treated freezing gait, symptomatic postural hypotension, or bothersome hallucinations
* Wheelchair bound or bedridden
* Utilizing or planning advanced PD therapies (DBS, infusion, etc.)
* History of delirium in the past year
* In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject able to complete PKG wear instructions per Patient Instruction Manual, or ability to comply with required study procedures and visit schedule)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
46 Years
Maximum Age:
83 Years
Study:
NCT03741920
Study Brief:
Protocol Section:
NCT03741920