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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT03984305
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to sign a written informed consent for study participation
* Presumed to have Levodopa responsive idiopathic Parkinson's Disease
* Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
* Has not been previously managed with the PKG
Exclusion Criteria:
* Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
* MoCA score \<23 at screening visit
* Diagnosis of Essential Tremor
* Wheelchair bound or bedridden
* Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
* 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 unable to complete PKG watch wear instructions per Patient Instruction Manual)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
46 Years
Maximum Age:
83 Years
Study:
NCT03984305
Study Brief:
Protocol Section:
NCT03984305