Parkinson Disease
Conditions
Keywords
Personal KinetiGraph (PKG) Movement Recording System, Objective Measurement
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).
Interventions
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.
DEVICEPersonal 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.
Sponsors
Global Kinetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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 results 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
46 Years to 83 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39) | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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. |
| Change in MDS-UPDRS Total From Baseline | From Baseline to the 1, 2 and 3-Year Annual Visits | 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). |
| Change in MDS-UPDRS Sub Part I | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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). |
| Change in PKG Bradykinesia Score (BKS) | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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. |
| Change in PKG Dyskinesia Score (DKS) | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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. |
| Change in PKG Fluctuation Score (FDS) | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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. |
| Percentage of Responders for Total MDS-UPDRS | 4 month Follow-up Visit | 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.) |
| Change in Levodopa Equivalent Dose (LED) | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | Change in LED from baseline to 4-months |
| PKG Patient Survey | Outcome measure evaluated at the 4-month Follow-up Visit | 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. |
| Change in MDS-UPDRS Sub Part II | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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). |
| Change in MDS-UPDRS Sub Part III | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | 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). |
| Change in MDS-UPDRS Sub Part IV | From Baseline to the 4-month Follow-up Visit | 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). |
| Change in PKG Percent Time Tremor (PTT) | From Baseline to the 4 month Follow-up Visit (approximately 3-9 months) | Change in the PKG reported percent time in tremor from baseline, max 100% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PKG+ Group 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 controlled or uncontrolled based on scores provided by the PKG.
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. | 23 |
| PKG- Group For subjects in the PKG- Group (SOC control 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.
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. | 18 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Sponsor Request due to Study Discontinuation | 19 | 15 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | PKG+ Group | Total | PKG- Group |
|---|---|---|---|
| Age, Continuous | 74.6 years STANDARD_DEVIATION 4.4 | 73.2 years STANDARD_DEVIATION 5.2 | 71.4 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 36 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 21 Participants | 37 Participants | 16 Participants |
| Region of Enrollment United States | 23 participants | 41 participants | 18 participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 16 Participants | 24 Participants | 8 Participants |
| Years since Parkinson's Disease Diagnosis | 5.4 years STANDARD_DEVIATION 4.7 | 6.3 years STANDARD_DEVIATION 4.5 | 6.3 years STANDARD_DEVIATION 4.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 18 |
| other Total, other adverse events | 12 / 23 | 3 / 18 |
| serious Total, serious adverse events | 3 / 23 | 1 / 18 |
Outcome results
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).
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned. Subjects were excluded from the analysis if they did not complete the 4 month Follow-up Visit or did not complete all parts of the MDS-UPDRS assessment at the Baseline and/or 4 month Follow-up Visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 0.9 score on a scale | Standard Deviation 19.9 |
| PKG- Group | Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 0.8 score on a scale | Standard Deviation 12 |
Secondary
Change in Levodopa Equivalent Dose (LED)
Change in LED from baseline to 4-months
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in Levodopa Equivalent Dose (LED) | 105.2 levodopa equivalent dose | Standard Deviation 229.5 |
| PKG- Group | Change in Levodopa Equivalent Dose (LED) | 61.7 levodopa equivalent dose | Standard Deviation 164.4 |
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).
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in MDS-UPDRS Sub Part I | -0.3 score on a scale | Standard Deviation 4.7 |
| PKG- Group | Change in MDS-UPDRS Sub Part I | 1.1 score on a scale | Standard Deviation 3.1 |
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).
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in MDS-UPDRS Sub Part II | 1.5 score on a scale | Standard Deviation 7.2 |
| PKG- Group | Change in MDS-UPDRS Sub Part II | -1.3 score on a scale | Standard Deviation 3.5 |
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).
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in MDS-UPDRS Sub Part III | -1.6 score on a scale | Standard Deviation 9.9 |
| PKG- Group | Change in MDS-UPDRS Sub Part III | -0.8 score on a scale | Standard Deviation 8.3 |
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).
Time frame: From Baseline to the 4-month Follow-up Visit
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in MDS-UPDRS Sub Part IV | 0.1 score on a scale | Standard Deviation 3.5 |
| PKG- Group | Change in MDS-UPDRS Sub Part IV | 0.1 score on a scale | Standard Deviation 2 |
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).
Time frame: From Baseline to the 1, 2 and 3-Year Annual Visits
Population: This Secondary Outcome Measure was not evaluated because the study was discontinued after completion of the 4-month Follow-up Visit. Subjects did not complete the 1, 2, or 3-Year Annual Follow-up Visits.
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.
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39) | 6.3 score on a scale | Standard Deviation 17.5 |
| PKG- Group | Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39) | -1.5 score on a scale | Standard Deviation 5.1 |
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.
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in PKG Bradykinesia Score (BKS) | -1.4 score on a scale | Standard Deviation 1.9 |
| PKG- Group | Change in PKG Bradykinesia Score (BKS) | -1.2 score on a scale | Standard Deviation 2.5 |
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.
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in PKG Dyskinesia Score (DKS) | 0.1 score on a scale | Standard Deviation 0.7 |
| PKG- Group | Change in PKG Dyskinesia Score (DKS) | 0.2 score on a scale | Standard Deviation 1.3 |
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.
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in PKG Fluctuation Score (FDS) | -0.2 score on a scale | Standard Deviation 1.3 |
| PKG- Group | Change in PKG Fluctuation Score (FDS) | -0.5 score on a scale | Standard Deviation 1.6 |
Secondary
Change in PKG Percent Time Tremor (PTT)
Change in the PKG reported percent time in tremor from baseline, max 100%
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PKG+ Group | Change in PKG Percent Time Tremor (PTT) | -1.6 percentage of time with tremor | Standard Deviation 6.5 |
| PKG- Group | Change in PKG Percent Time Tremor (PTT) | -1.6 percentage of time with tremor | Standard Deviation 5.9 |
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.)
Time frame: 4 month Follow-up Visit
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PKG+ Group | Percentage of Responders for Total MDS-UPDRS | 6 Participants |
| PKG- Group | Percentage of Responders for Total MDS-UPDRS | 3 Participants |
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.
Time frame: Outcome measure evaluated at the 4-month Follow-up Visit
Population: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PKG+ Group | PKG Patient Survey | 13 Participants |
| PKG- Group | PKG Patient Survey | 10 Participants |