Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson’s Disease Status (APPRISE)
Sponsor:
Brief Summary:
system data in the clinical management of Parkinson’s disease (PD) in routine clinical care
at a movement disorders clinic. Specifically:
1. Measure medication use and clinical management plan changes in a large, multicenter
cohort among participants undergoing a clinical assessment with an MDS in which the MDS
reviews the participant’s PKG during the clinical assessment in half of the enrolled
participants (PKG + Group) and in half of the enrolled participants the MDS completes
the clinical assessment without the PKG (PKG- Group).
2. Determine the association between frequency of medication changes, the PKG information,
and other clinical assessments among participants with and without a PKG report of their
PD motor status available to the clinician at the time of evaluation.
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)
Locations
- Sutter Health, Sacramento, California, United States, 95816
- University of California, San Diego, California, United States, 92037
