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The main objective of this study is to evaluate whether persons with Parkinson's disease (PwP) whose Parkinson's disease (PD) symptoms are uncontrolled have improved clinical patient outcomes and quality of life when managed with the aid of objective measurement and use of PKG target ranges compared to PwP treated using only standard of care (SOC) (medical history, physical examination).
This is a randomized controlled trial (RCT) to compare the value of the Personal KinetiGraph® (PKG®) System and SOC vs. the SOC alone for treatment of PwP. The study aims to evaluate clinical outcomes, quality of life outcomes, health economic benefits, duration of controlled status, and need for additional PD treatment through 3 years follow-up of PwP specifically treated to a target range when using the PKG data in the clinical management of PD in routine clinical care compared to those managed with SOC alone. All subjects will be treated by Movement Disorder Specialists and General Neurologists with expertise in PD. Both groups will be recommended to undergo treatment changes until they reach a "controlled state" that is determined by either the clinician using SOC (PKG- Group) or using recommended target ranges for PKG scores and SOC assessments (PKG+ Group). Investigators will utilize standard available treatments to manage these PwP in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PKG+ Group | Experimental | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator 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.The PKG will be used to determine if the subject is in the target range or out of the target range based on scores provided by the PKG. |
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| PKG- Group | Placebo Comparator | For subjects in the PKG- Group, participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personal KinetiGraph® (PKG®) System | Device | The Personal KinetiGraph (PKG®) System consists of the following:
The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® also provides an assessment of daytime somnolence and an indication of propensity for impulsive behaviors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The change in MDS-UPDRS Total score at 4 months from baseline defined as sections I, II, III (per core lab measurement) and IV in PwP. The endpoint will be compared between subjects out of target at baseline for those who are treated with SOC and PKG data (PKG+ Group) versus those who are treated per SOC alone (PKG- Group). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate for total MDS-UPDRS | Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of >4 points (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.). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (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). |
| Measure | Description | Time Frame |
|---|---|---|
| Levodopa Equivalent Dose (LED) | Levodopa Equivalent Dose (LED) at each visit | 4 months, 1 year, 2 years, 3 years |
| PKG Patient Survey | Analyze PKG usability with the PKG Patient reported survey. Questions 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja Mehanna, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30032695 | Background | 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. | |
| 20065131 | Background |
| Label | URL |
|---|---|
| Sponsor website | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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).
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Subjects will remain blinded to treatment group throughout the life of the trial. Investigator and research staff will be unblinded to the treatment group as they will or will not have access to the PKG data to be incorporated into their standard of care practice.
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| Personal KinetiGraph® (PKG®) Watch | Device | The Personal KinetiGraph (PKG®) System consists of the following:
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| 4 months |
| Responder rate for PKG | Percent "responders" by PKG (defined as BKS change of >2 point improvement) | 4 months |
| Change in MDS-UPDRS motor endpoints | Change in MDS-UPDRS Part III (per core lab measurement). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Part III is the motor examination and contains 33 questions/evaluations. 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). | 4 months, 1 year, 2 years, 3 years |
| Change in MDS-UPDRS total | Change in MDS-UPDRS Total score from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (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). | 1 year, 2 years, 3 years |
| Change in MDS-UPDRS sub parts | Change in the non-motor (parts I and II) score and change in Part IV for the MDS-UPDRS from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (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). | 4 months, 1 year, 2 years, 3 years |
| Change in PKG Bradykinesia Score (BKS) | Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia. | 4 months, 1 year, 2 years, 3 years |
| Change in PKG Dyskinesia score (DKS) | Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia. | 4 months, 1 year, 2 years, 3 years |
| Change in Percent Time in Tremor (PTT) | Change in the PKG reported PTT from baseline, max 100%. A PTT of >1% indicates that tremor is present. | 4 months, 1 year, 2 years, 3 years |
| Change in Fluctuation Dyskinesia score (FDS) | Change in the PKG reported FDS from baseline. The higher the score, the more severe the fluctuation, and a FDS of 7.5-13 indicates controlled fluctuations. | 4 months, 1 year, 2 years, 3 years |
| Change in Percent Time Immobile (PTI) | Change in the PKG reported PTI from baseline, max 100%. A PTI of >5% is considered high. | 4 months, 1 year, 2 years, 3 years |
| 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. | 4 months, 1 year, 2 years, 3 years |
| Number of Interim Visits | Number of interim visits conducted from baseline to 4 months in each arm | 4 months |
| 4 months, 1 year, 2 years, 3 years |
| Healthcare Utilization | Rate of protocol defined adverse events affecting health care utilization from baseline | 4 months, 1 year, 2 years, 3 years |
| Potential Contraindications | Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline | 4 months, 1 year, 2 years, 3 years |
| Lifestyle Factors Impacted by PD | Rate of protocol defined lifestyle factors impacted by PD | 4 months, 1 year, 2 years, 3 years |
| Work Productivity and Activity Impairment | Change in Work Productivity and Activity Impairment Questionnaire (WPAI) from baseline. The WPAI Questionnaire includes questions regarding impacts to work productivity due to PD symptoms. | 4 months, 1 year, 2 years, 3 years |
| PKG scores | Proportion of enrolled subjects in PKG+ group who are either unable to be brought into the target range or unable to be brought to a BKS ≤26. A higher score represents more severe bradykinesia. | 4 months, 1 year, 2 years, 3 years |
| 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |