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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 below

Select...

My condition improves with dopamine-based medication.

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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

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

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.

0 / 2Eligibility criteria met

Find a Location

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

Media Library

Personal KinetiGraph™ (PKG™) Clinical Trial Eligibility Overview. Trial Name: NCT03741920 — N/A

Parkinson's Disease Research Study Groups: Personal KinetiGraph™ (PKG™) -, Personal KinetiGraph™ (PKG™) +

Parkinson's Disease Clinical Trial 2023: Personal KinetiGraph™ (PKG™) Highlights & Side Effects. Trial Name: NCT03741920 — N/A

Personal KinetiGraph™ (PKG™) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03741920 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Under what criteria can individuals become participants in this research project?

"In order to qualify for this medical trial, applicants should be between the ages of 46 and 83 and have been diagnosed with Parkinson's disease. The research team is looking for about 231 willing participants in total."

Answered by AI

Is this trial currently available to participants?

"Per the records found on clinicaltrials.gov, this study is not currently seeking additional enrollees as it was last edited in March of 2020. However, 488 other trials are presently enrolling patients at this time."

Answered by AI

How many locations in North America are facilitating this investigation?

"For this trial, University of Miami in Miami, University of Florida in Gainesville and Parkinson's disease and Movement Disorders Center in Boca Raton are 3 sites among 12 available."

Answered by AI

Is enrollment currently allowed for individuals aged under eighty?

"According to the stipulated criteria, only individuals aged 46-83 are able to participate in this research. Moreover, there exist 27 trials for minors and 485 studies with eligibility requirements of 65+."

Answered by AI