Utilization of Target Ranges to Treat Parkinson's Disease With the PKG

Parkinson Disease Clinical Trial

— TARGET-PD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03984305
• Other study ID #: Study 003
• Status: Terminated
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: October 16, 2020

Study information

• Verified date: August 2021
• Source: Global Kinetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 46 Years to 83 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Personal KinetiGraph® (PKG®) Watch
The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording.
• Personal KinetiGraph® (PKG®) Report
The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Parkinson's Disease and Movement Disorders Center of Long Island	Commack	New York
United States	Michigan State University	East Lansing	Michigan
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	Neurology Center of New England	Foxboro	Massachusetts
United States	University of Florida	Gainesville	Florida
United States	University of Texas	Houston	Texas
United States	Marshall University	Huntington	West Virginia
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada
United States	University of Arkansas Medical Center	Little Rock	Arkansas
United States	Parkinson's Disease and Movement Disorders Center of Silicon Valley	Menlo Park	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Weill Cornell	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Kaiser Mid-Atlantic Permanente Center	Rockville	Maryland
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Global Kinetics Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Percentage of Responders for Total MDS-UPDRS	Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of 4.3 (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.)	4 month Follow-up Visit
Secondary	Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39)	Change in the patient reported quality of life questionnaire PDQ-39 from Baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in MDS-UPDRS Total From Baseline	The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).	From Baseline to the 1, 2 and 3-Year Annual Visits
Secondary	Change in MDS-UPDRS Sub Part I	Change in sub part I of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part I assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part I is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in PKG Bradykinesia Score (BKS)	Change in the PKG reported scores BKS from baseline. Reported on a scale from 0-80. The higher the number, the more severe the bradykinesia.	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in PKG Dyskinesia Score (DKS)	Change in the PKG reported scores DKS from baseline. Reported on a scale of 0-355 with the higher the score, the more severe the dyskinesia.	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in PKG Fluctuation Score (FDS)	Change in the PKG reported scores FDS from baseline reported as a score of 0-45. The higher the score, the more severe the fluctuation.	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in PKG Percent Time Tremor (PTT)	Change in the PKG reported percent time in tremor from baseline, max 100%	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in Levodopa Equivalent Dose (LED)	Change in LED from baseline to 4-months	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	PKG Patient Survey	Analyze PKG usability with the PKG Patient reported survey, specifically the percentage of subjects that strongly agree when asked if they would be willing to use the PKG again to assist in the management of Parkinson's disease. Questions in the survey are on a scale of strongly agree to strongly disagree and will be patient reported information related to their use of the PKG watch. Both treatment groups will be administered the survey and scores will be aggregated by group and compared.	Outcome measure evaluated at the 4-month Follow-up Visit
Secondary	Change in MDS-UPDRS Sub Part II	Change in sub part II of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part II assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part II is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in MDS-UPDRS Sub Part III	Change in sub part III of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part III assesses the motor impact of Parkinson's disease and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part III is 0 and the maximum score is 132. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).	From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary	Change in MDS-UPDRS Sub Part IV	Change in Part IV of the MDS-UPDRS from Baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part IV evaluates motor symptoms and contains 6 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part IV is 0 and the maximum score is 24. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).	From Baseline to the 4-month Follow-up Visit

External Links

•   Sponsor website