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A Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status.
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE).
 
Region Sponsors
California - Northern
Global Kinetics Corporation
 
Acronym KP IRB No.
PKG 1363572
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Parkinson Disease;
 
Purpose
The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically: 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); 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;
 
Detailed Description
Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE). Evaluation of treatment changes with or without the use of PKG data, Time Frame: 90 day. The proportion of patients in which the clinical management plan was changed in patients followed in the PKG- Group (clinician standard of care) compared to the PKG+ Group (clinician standard of care with the use of PKG data.
 
Gender Age Limit
Male & Female 46 - 83 years
 
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)

 
Keywords and/or Specific Medical Conditions
  • Basal Ganglia Diseases
  • Neurodegenerative Diseases
  • Brain Diseases
  • Parkinson Disease
  • Central Nervous System Diseases
  • Parkinsonian Disorders
  • Movement Disorders
  • Neurology (Neurological Disorders)
  • Nervous System Diseases
 
KP Clinical Facility
  • Redwood City Medical Center
  • Sacramento Medical Center
  • San Leandro Medical Center
  • San Rafael Medical Center
 
Clinical Area
  • Neurology (Neurological Disorders)


Principal Investigator:
Suketu M Khandhar, MD
Contact Information:
- Tashia Orr
-tashia.orr@kp.org
-Sacramento Medical Center


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