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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)

Must not have

Wheelchair bound or bedridden

Contraindication to increasing dopaminergic therapy, such as current or treated freezing gait, symptomatic postural hypotension, or bothersome hallucinations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 day

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition improves with dopamine-based medication.

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I am between 46 and 83 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to walk and use a wheelchair or stay in bed.

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I cannot increase my dopamine therapy due to side effects like freezing gait, low blood pressure when standing, or hallucinations.

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I am using or planning to use advanced treatments for Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of treatment changes with or without the use of PKG data

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met