Trial Outcomes & Findings for Utilization of Target Ranges to Treat Parkinson's Disease With the PKG (NCT NCT03984305)
NCT ID: NCT03984305
Last Updated: 2022-02-08
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Results posted on
2022-02-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
18
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Sponsor Request due to Study Discontinuation
|
19
|
15
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Utilization of Target Ranges to Treat Parkinson's Disease With the PKG
Baseline characteristics by cohort
| Measure |
PKG+ Group
n=23 Participants
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.
|
PKG- Group
n=18 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.6 years
STANDARD_DEVIATION 4.4 • n=93 Participants
|
71.4 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
73.2 years
STANDARD_DEVIATION 5.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=93 Participants
|
18 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Years since Parkinson's Disease Diagnosis
|
5.4 years
STANDARD_DEVIATION 4.7 • n=93 Participants
|
6.3 years
STANDARD_DEVIATION 4.4 • n=4 Participants
|
6.3 years
STANDARD_DEVIATION 4.5 • n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
PKG- Group
n=11 Participants
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.
|
PKG+ Group
n=16 Participants
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.
|
|---|---|---|
|
Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
|
0.8 score on a scale
Standard Deviation 12.0
|
0.9 score on a scale
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: 4 month Follow-up VisitPopulation: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
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.)
Outcome measures
| Measure |
PKG- Group
n=11 Participants
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.
|
PKG+ Group
n=16 Participants
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.
|
|---|---|---|
|
Percentage of Responders for Total MDS-UPDRS
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PKG- Group
n=15 Participants
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.
|
PKG+ Group
n=19 Participants
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.
|
|---|---|---|
|
Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39)
|
-1.5 score on a scale
Standard Deviation 5.1
|
6.3 score on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: From Baseline to the 1, 2 and 3-Year Annual VisitsPopulation: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
PKG- Group
n=15 Participants
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.
|
PKG+ Group
n=18 Participants
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.
|
|---|---|---|
|
Change in MDS-UPDRS Sub Part I
|
1.1 score on a scale
Standard Deviation 3.1
|
-0.3 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PKG- Group
n=14 Participants
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.
|
PKG+ Group
n=19 Participants
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.
|
|---|---|---|
|
Change in PKG Bradykinesia Score (BKS)
|
-1.2 score on a scale
Standard Deviation 2.5
|
-1.4 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PKG- Group
n=14 Participants
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.
|
PKG+ Group
n=19 Participants
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.
|
|---|---|---|
|
Change in PKG Dyskinesia Score (DKS)
|
0.2 score on a scale
Standard Deviation 1.3
|
0.1 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PKG- Group
n=14 Participants
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.
|
PKG+ Group
n=19 Participants
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.
|
|---|---|---|
|
Change in PKG Fluctuation Score (FDS)
|
-0.5 score on a scale
Standard Deviation 1.6
|
-0.2 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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.
Change in the PKG reported percent time in tremor from baseline, max 100%
Outcome measures
| Measure |
PKG- Group
n=14 Participants
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.
|
PKG+ Group
n=19 Participants
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.
|
|---|---|---|
|
Change in PKG Percent Time Tremor (PTT)
|
-1.6 percentage of time with tremor
Standard Deviation 5.9
|
-1.6 percentage of time with tremor
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 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.
Change in LED from baseline to 4-months
Outcome measures
| Measure |
PKG- Group
n=15 Participants
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.
|
PKG+ Group
n=19 Participants
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.
|
|---|---|---|
|
Change in Levodopa Equivalent Dose (LED)
|
61.7 levodopa equivalent dose
Standard Deviation 164.4
|
105.2 levodopa equivalent dose
Standard Deviation 229.5
|
SECONDARY outcome
Timeframe: Outcome measure evaluated at the 4-month Follow-up VisitPopulation: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
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 measures
| Measure |
PKG- Group
n=15 Participants
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.
|
PKG+ Group
n=19 Participants
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.
|
|---|---|---|
|
PKG Patient Survey
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
PKG- Group
n=15 Participants
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.
|
PKG+ Group
n=18 Participants
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.
|
|---|---|---|
|
Change in MDS-UPDRS Sub Part II
|
-1.3 score on a scale
Standard Deviation 3.5
|
1.5 score on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
PKG- Group
n=11 Participants
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.
|
PKG+ Group
n=16 Participants
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.
|
|---|---|---|
|
Change in MDS-UPDRS Sub Part III
|
-0.8 score on a scale
Standard Deviation 8.3
|
-1.6 score on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: From Baseline to the 4-month Follow-up VisitPopulation: The primary analysis is based on the intent-to-treat population defined as all randomized subjects analyzed according to the treatment group assigned.
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).
Outcome measures
| Measure |
PKG- Group
n=15 Participants
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.
|
PKG+ Group
n=18 Participants
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.
|
|---|---|---|
|
Change in MDS-UPDRS Sub Part IV
|
0.1 score on a scale
Standard Deviation 2.0
|
0.1 score on a scale
Standard Deviation 3.5
|
Adverse Events
PKG+ Group
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
PKG- Group
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PKG+ Group
n=23 participants at risk
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.
|
PKG- Group
n=18 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Inpatient Hospitalization
|
8.7%
2/23 • Number of events 2 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
|
Infections and infestations
Inpatient Hospitalization
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
0.00%
0/18 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
Other adverse events
| Measure |
PKG+ Group
n=23 participants at risk
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.
|
PKG- Group
n=18 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
26.1%
6/23 • Number of events 8 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
|
Vascular disorders
Orthostatic Hypotension
|
17.4%
4/23 • Number of events 6 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
|
Psychiatric disorders
Bothersome Hallucinations
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
0.00%
0/18 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
|
General disorders
Emergency Room Visit
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
0.00%
0/18 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
|
Infections and infestations
Urgent Care Visit
|
8.7%
2/23 • Number of events 2 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
0.00%
0/18 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
|
Gastrointestinal disorders
Unanticipated Clinic Visit
|
4.3%
1/23 • Number of events 1 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
0.00%
0/18 • Adverse Events were collected at the time of enrollment through the 4-Month Follow-up Visits, which was a time period of approximately 1 year.
Only the following protocol defined adverse events were collected during this post-market study: falls, orthostatic hypotension, bothersome hallucinations, delirium, impairment that prohibits interaction with the PKG Watch, hospitalizations, Emergency Department visits, urgent care visits and unanticipated clinic visits.
|
Additional Information
Director of Clinical Affairs
Global Kinetics Corporation
Phone: 612.240.2437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A participating institution/PI may publish its individual site results; however, the sponsor has the exclusive right to publish the complete accumulated results of the multi-center trial. If a manuscript for the multi-center publication has not been submitted within 12 months of the conclusion or termination of the trial, then the institution/PI may publish a subset of the trial results. The sponsor shall be acknowledged in accordance with scientific practice.
- Publication restrictions are in place
Restriction type: OTHER