Parkinson Disease
Conditions
Keywords
Personal KinetiGraph® (PKG®) System, Objective Measurement
Brief summary
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).
Detailed description
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.
Interventions
The Personal KinetiGraph (PKG®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch * Data-driven report known as the PKG® 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.
The Personal KinetiGraph (PKG®) System consists of the following: * A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period * Proprietary algorithms to translate raw movement data collected by the PKG® Watch
Sponsors
Global Kinetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
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.
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).
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to sign a written informed consent for study participation and comply with all required follow-up visits * Presumed to have levodopa responsive PD * Taking levodopa for at least 30 days prior to screening visit * Planning to continue using levodopa for PD throughout study participation * Able to increase levodopa by a minimum of 100mg/day * Age inclusive at the time of consent of 55-80 years * Has not received a PKG in the last 12 months
Exclusion criteria
* Evidence of atypical or secondary parkinsonism * Presence of any non-parkinsonian tremors * Contraindication to increasing levodopa * Requires the addition of or dose adjustment of an anti-dyskinesia medication within the next 4 months * Those who have received advanced therapies including individuals no longer actively utilizing these therapies, or planning to receive advanced therapies in the next 6 months * MoCA score \<23 at screening visit * Bedridden, wheelchair confined, or requires the regular use of an assistive gait device * Predominant sleep period is during the daytime hours of 9am to 6pm (e.g. third shift worker) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 4 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in MDS-UPDRS total | 1 year, 2 years, 3 years | 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). |
| Change in PKG Bradykinesia Score (BKS) | 4 months, 1 year, 2 years, 3 years | Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia. |
| Change in PKG Dyskinesia score (DKS) | 4 months, 1 year, 2 years, 3 years | Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia. |
| Change in Percent Time in Tremor (PTT) | 4 months, 1 year, 2 years, 3 years | Change in the PKG reported PTT from baseline, max 100%. A PTT of \>1% indicates that tremor is present. |
| Change in Fluctuation Dyskinesia score (FDS) | 4 months, 1 year, 2 years, 3 years | 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. |
| Change in Percent Time Immobile (PTI) | 4 months, 1 year, 2 years, 3 years | Change in the PKG reported PTI from baseline, max 100%. A PTI of \>5% is considered high. |
| Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39) | 4 months, 1 year, 2 years, 3 years | 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. |
| Number of Interim Visits | 4 months | Number of interim visits conducted from baseline to 4 months in each arm |
| Responder rate for total MDS-UPDRS | 4 months | 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). |
| Responder rate for PKG | 4 months | Percent responders by PKG (defined as BKS change of \>2 point improvement) |
| Change in MDS-UPDRS motor endpoints | 4 months, 1 year, 2 years, 3 years | 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). |
| Change in MDS-UPDRS sub parts | 4 months, 1 year, 2 years, 3 years | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization | 4 months, 1 year, 2 years, 3 years | Rate of protocol defined adverse events affecting health care utilization from baseline |
| Potential Contraindications | 4 months, 1 year, 2 years, 3 years | Rate of protocol defined adverse events and potential contraindications for increasing dopaminergic therapy from baseline |
| Lifestyle Factors Impacted by PD | 4 months, 1 year, 2 years, 3 years | Rate of protocol defined lifestyle factors impacted by PD |
| Work Productivity and Activity Impairment | 4 months, 1 year, 2 years, 3 years | 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. |
| PKG scores | 4 months, 1 year, 2 years, 3 years | 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. |
| PKG Patient Survey | 4 months, 1 year, 2 years, 3 years | 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. |
| Levodopa Equivalent Dose (LED) | 4 months, 1 year, 2 years, 3 years | Levodopa Equivalent Dose (LED) at each visit |
Outcome results
None listed