Clinical trial NCT03984305: Utilization of Target Ranges to Treat Parkinson's Disease With the PKG
Official title: Utilization of Target Ranges to Treat Patients With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Keywords: Personal KinetiGraph (PKG) Movement Recording System
Objective Measurement
Lead sponsor: Global Kinetics Corporation
Sponsor class: INDUSTRY
First posted: 2019-06-13
Enrollment: 41
Sex: ALL
Minimum age (years): 46
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).

Detailed description: This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).

Eligibility criteria: Inclusion Criteria:

* Able and willing to sign a written informed consent for study participation
* Presumed to have Levodopa responsive idiopathic Parkinson's Disease
* Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
* Has not been previously managed with the PKG

Exclusion Criteria:

* Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
* MoCA score \<23 at screening visit
* Diagnosis of Essential Tremor
* Wheelchair bound or bedridden
* Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
* 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 unable to complete PKG watch wear instructions per Patient Instruction Manual)

Primary outcomes:
measure: Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary outcomes:
measure: Percentage of Responders for Total MDS-UPDRS
timeFrame: 4 month Follow-up Visit
measure: Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39)
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in MDS-UPDRS Total From Baseline
timeFrame: From Baseline to the 1, 2 and 3-Year Annual Visits
measure: Change in MDS-UPDRS Sub Part I
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in PKG Bradykinesia Score (BKS)
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in PKG Dyskinesia Score (DKS)
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in PKG Fluctuation Score (FDS)
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in PKG Percent Time Tremor (PTT)
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in Levodopa Equivalent Dose (LED)
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: PKG Patient Survey
timeFrame: Outcome measure evaluated at the 4-month Follow-up Visit
measure: Change in MDS-UPDRS Sub Part II
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in MDS-UPDRS Sub Part III
timeFrame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
measure: Change in MDS-UPDRS Sub Part IV
timeFrame: From Baseline to the 4-month Follow-up Visit
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas Medical Center
state: Arkansas
city: Menlo Park
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Silicon Valley
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Rockville
country: United States
facility: Kaiser Mid-Atlantic Permanente Center
state: Maryland
city: Foxboro
country: United States
facility: Neurology Center of New England
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: Commack
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Long Island
state: New York
city: New York
country: United States
facility: Weill Cornell
state: New York
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Huntington
country: United States
facility: Marshall University
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Raja Mehanna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.
citation: Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.