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PKG Monitoring for Parkinson's Disease (APPRISE Trial)
N/A
Waitlist Available
Led By Rajesh Pahwa, MD
Research Sponsored by Global Kinetics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Responsive to dopaminergic medications
Age 46 - 83 years at the time of consent (per PKG Indications for Use, see Technical Instructions Manual)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 day
Awards & highlights
APPRISE Trial Summary
This trial is looking at whether the Personal KinetiGraph movement recording system data is useful in the clinical management of Parkinson's disease.
Who is the study for?
This trial is for people aged 46-83 with Parkinson's Disease who respond to dopaminergic medications. They must be able to consent and not wheelchair-bound or bedridden. Those with conditions like freezing gait, low blood pressure, hallucinations, delirium in the past year, or using advanced therapies can't join.Check my eligibility
What is being tested?
The study tests if the Personal KinetiGraph (PKG) device helps doctors better manage Parkinson's by comparing changes in treatment plans when they have PKG data versus when they don't during patient assessments.See study design
What are the potential side effects?
Since this trial involves a non-invasive monitoring device rather than medication, there are no direct side effects from interventions being studied.
APPRISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition improves with dopamine-based medication.
Select...
I am between 46 and 83 years old.
APPRISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of treatment changes with or without the use of PKG data
APPRISE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Personal KinetiGraph™ (PKG™) +Experimental Treatment1 Intervention
For subjects in the PKG+ Group, the study MDS will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment. PKG results will be recorded in the PKG Reporting case report form (CRF). The study MDS will complete the MDS-Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures along with the PKG information.
Group II: Personal KinetiGraph™ (PKG™) -Active Control1 Intervention
For subjects in the PKG- Group (control group), the study Movement Disorder Specialist (MDS) will complete the MDS - Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures. The study Movement Disorder Specialist will be blinded to the PKG information until the second part of the 90-day follow-up visit.
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Who is running the clinical trial?
Global Kinetics CorporationLead Sponsor
3 Previous Clinical Trials
541 Total Patients Enrolled
Rajesh Pahwa, MDPrincipal InvestigatorUniversity of Kansas Medical Center
5 Previous Clinical Trials
231 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to walk and use a wheelchair or stay in bed.My condition improves with dopamine-based medication.I am between 46 and 83 years old.I cannot increase my dopamine therapy due to side effects like freezing gait, low blood pressure when standing, or hallucinations.You have experienced delirium in the past year.I am using or planning to use advanced treatments for Parkinson's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Personal KinetiGraph™ (PKG™) -
- Group 2: Personal KinetiGraph™ (PKG™) +
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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