Personal KinetiGraph® Clinical Validation Study
Conditions: Movement Disorders, Parkinson Disease
Sponsor: Global Kinetics Corporation

 
Protocol: Personal KinetiGraph® Clinical Validation Study 
 
 
 
 
 
 
 
 
Clinical Study Protocol 
 
 
Protocol Number: Study 006 
Protocol Version 2.0  
Date:  June 23, 2022 
 
 
 
 
 
 
 
Study Sponsor:  Global Kinetics Pty Ltd 
 
Principal Investigator:  
Zoltan Mari, MD  
Z Neurosciences, LLC. (NPI #1366480048) 
7371 W Charleston Blvd, Suite #110 
Las Vegas, NV 89117  

PKG Control Data Update 
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Protocol Revision History 
Revision 
Description of Change 
Date 
1.0 
Initial Release 
 September 1, 2021 
1.1 
Clarifications made during initial review  
 September 28, 2021 
2.0 
• Updated Sponsor name from Global Kinetics 
Corporation (GKC) to Global Kinetics Pty Ltd (GK) 
• Included most recent 510(k) clearance 
• Added graphics of the Gen 3.0 PKG Watch 
• Added Docking Station and PKG Portal descriptions 
• Changed the age criteria to ≥18 
• Added product usability and satisfaction 
assessment questionnaire  
• Added the evaluation of product usability as a 
Secondary Endpoint  
June 23, 2022 

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TABLE OF CONTENTS 
1 
PROTOCOL SIGNATURE PAGE ............................................................................................................... 4 
1. 
PURPOSE ............................................................................................................................................... 5 
2. 
BACKGROUND ....................................................................................................................................... 5 
3. 
PRODUCT DESCRIPTION ........................................................................................................................ 7 
4. 
STUDY DESIGN....................................................................................................................................... 9 
5. 
SCREENING VISIT ................................................................................................................................. 10 
6. 
FOLLOW-UP VISIT ................................................................................................................................ 12 
7. 
STUDY ENDPOINTS .............................................................................................................................. 13 
8. 
STATISTICS ........................................................................................................................................... 13 
9. 
INVESTIGATOR QUALIFICATIONS ........................................................................................................ 14 
10. INSTITUTIONAL REVIEW BOARD ......................................................................................................... 14 
11. PROTOCOL DEVIATIONS ...................................................................................................................... 14 
12. BENEFIT/RISK ANALYSIS ...................................................................................................................... 14 
13. REFERENCES ........................................................................................................................................ 16 
 
 
 
 
 
 
 
 
 
 
 

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1 
PROTOCOL SIGNATURE PAGE 
 
Title:    Personal KinetiGraph® Clinical Validation Study 
 
 
I have reviewed this protocol and agree to adhere to the requirements and responsibilities listed 
herein.  I am trained to the contents of this protocol and the specific use of the devices listed in 
this protocol.  I will ensure that the study is conducted in compliance with the protocol, Good 
Clinical Practices ISO14155, Declaration of Helsinki, and all applicable regulatory requirements.  
 
 
 
 
_______________________________  
 
_____________________ 
Site Principal Investigator Signature  
 
Date (DD/MMM/YYY) 
 
 
 
_______________________________ 
 
Site Principal Investigator Printed Name 

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1. PURPOSE 
The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® 
(PKG®).   
 
2. BACKGROUND 
Overview 
Patient management is increasingly assisted by and dependent on data obtained from objective 
measurements of various biomarkers.  Monitoring motor activity by continuous collection of 
accurate, ecologically valid, and functionally relevant objective movement data is critical in a 
group of neurological diseases, known as movement disorders, in which impaired motor control 
is central to the disability that movement disorder patients experience.  The phenomenology of 
abnormal movements can vary from too little (akinesia, bradykinesia, hypokinesia) to too much 
(hyperkinesias), may be fast (myoclonus, tic) or slow (athetosis), regular (tremor) or irregular 
(chorea) across and within the various movement disorders.1  In almost all cases, the severity 
and pattern of abnormal movements will vary, making spot assessments, such as an in-person 
clinical exam, an often inaccurately representative sample of the patient's typical state or of the 
movement abnormality's severity and character.  The potential for in-person clinic exams to be 
poorly representative of the patient's actual motor impairment further increases by the 
unnatural testing and exam items/tasks, often minimally related to motor activities functionally 
relevant to the patient, in an unnatural environment.  Furthermore, the amount of data 
obtained in a spot exam in the setting of a clinical visit will inherently be very limited.  As a 
result, patient management may be based on inaccurate, ecologically invalid, and functionally 
irrelevant exam data. 
 
Adding novel sources of data, including objective, ecologically valid, continuous as opposed to 
spot samples, can optimize patient management.  The power and potential of continuous 
monitoring of movement disorders lies in allowing us to collect accurate, objective data during 
all waking hours and determine changes in motor behavior relative to anything clinically 
relevant, such as medication timing, activities of daily living, changes in therapy, and many 
other factors that can be recorded and correlated with the objectively measured and 
quantified, analyzed motor functions and behaviors.  This approach is nothing short of 
revolutionary when compared to traditional in-person care in our quest to advise and inform 
the best possible decision-making in the clinical care of movement disorders. 
 
Parkinson’s Disease (PD) is the most common hypokinetic movement disorder and is a chronic, 
progressive movement disorder that affects as many as one million people in the United 
States.2-5  The main motor (or movement) related symptoms of PD are bradykinesia (slowness 
of movement), rigidity, tremors and postural instability. Other symptoms include speech and 

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swallowing difficulties, cognitive impairment, depression or other emotional changes. As the 
disease progresses, symptoms may interfere with daily activities. Approximately 40% of 
patients develop fluctuations and dyskinesia after 4-6 years of treatment and 70% after long-
term treatment (>9 years). Patients with fluctuations tend to have greater disease severity and 
disability, and those that fail to derive adequate benefit from medications report poorer quality 
of life.6-7  
 
Personal KinetiGraph® (PKG®) System History 
Early PKG validation studies were used to obtain initial regulatory clearance/approvals in the 
US, Europe/UK and Australia.6-12  The primary research data to support these approvals 
included the original PKG BKS and DKS algorithm development and comparisons to the Unified 
Parkinson’s Disease Rating Scale (UPDRS) and Abnormal Involuntary Movement Scale (AIMS) 
against a control group as published in Griffiths et al. 2012.6 Additional literature references to 
support substantial equivalence for FDA 510(k) clearance were also provided to FDA.   
 
Regulatory Clearance 
The PKG Movement Recording System received FDA 510(k) clearance on August 22, 2014 
(K140086).  The Personal Kinetigraph (PKG) System is intended to quantify kinematics of 
movement disorder symptoms in conditions such as Parkinson's disease, including tremor, 
bradykinesia and dyskinesia. It includes a medication reminder, an event marker and is 
intended to monitor activity associated with movement during sleep. 510(k) clearance for the 
2nd Generation of the PKG system was issued by FDA on September 20, 2016 (K161717) for 
Model: GKC-2000 (Gen 2). The system components were updated to include:  
• The PKG Watch (movement data logger) 
• The PKG Tablet 
• The PKG Clinic Server (Portal) 
• The PKG report, and the PKG Accessories.  
 
On March 11, 2022, 510(k) clearance was issued by the FDA, which allows the use of the PKG 
System continuously in the home environment with clearance of the docking station and dock 
cable (K211887). Future generations of the PKG Movement Recording System will be cleared by 
the FDA through the regulatory approval process prior to being utilized in this clinical study. All 
commercially available versions of the PKG System and associated product instructions for use 
may be used in this study. The study is a post-market study and the system will be used within 
its FDA-cleared indication for use. 
 
The current U.S. labelling limits the age of patients who are indicated to use the PKG Watch.  
Based on feedback obtained from clinicians using this device in routine clinical care and in 
particular in IRB-approved clinical studies, the age restriction in the cleared indications for use 

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limit the enrollment of subjects into clinical studies.  Additionally, it has been determined that 
for the clinical studies, that the indication statement including the age not only applies at the 
point of enrollment, but also at each point in which the PKG Watch is worn in the study over 
the 3-year follow-up period.  Currently, enrolled subjects who are qualified at the start of the 
study may exceed the age limit as they progress through the required follow-up period. The age 
restriction was required by FDA in the labeled indications for use, since the ages collected in the 
age-matched control data provided in Griffiths et al. 2012 only included this range in the 
sample data set. Additionally, the proprietary measures captured on the PKG may vary slightly 
with age. This makes it important to how these measures have changed over time since the 
original data published in 2012, change with PD disease progression (e.g., as age increases, PD 
symptoms may worsen including increase in bradykinesia, decrease in dyskinesia, increase in 
fluctuations) and to allow for adjustments as needed. 
 
 
3. PRODUCT DESCRIPTION 
 
Personal KinetiGraph (PKG®) Movement Recording System  
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 Global Kinetics (GK). 
 
The PKG Watch 
The PKG Watch (Figure 1) is a wrist worn medical device that looks like a wristwatch. It contains 
a rechargeable battery, a triaxial accelerometer, memory, an optional vibration and indicator 
light-based reminder to the subject when PD medications are due and a means for recording 
when Parkinson’s disease (PD) medications were taken, as well as a capacitive sensor to detect 
removal from the wrist.  
 
Subjects wear the device for varying periods of time enabling remote monitoring. During this 
wear time the PKG Watch automatically collects data on the type of movement experienced by 
the patient 24 hours per day, can remind the patient to register when they have taken their PD 
medication as prescribed by their physician, and the patient can indicate when he/she has 
taken each prescribed dose of PD medication. 
 
 
 
 
 
 
Figure 1: 
PKG Watch Gen 2.0 
 
PKG Watch Gen 3.0 
 

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Docking Station  
The docking station includes charging and communication functions. At the end of the recording period, 
the PKG Watch is placed on a cellular-enabled docking station to charge the watch battery and upload 
the data to the cloud. Data is then processed via proprietary algorithms and output into a PKG Clinician 
Report and PKG Patient Report.   
 
PKG Portal 
The PKG Portal is a secure web application that can be used to create new patient records, place new 
PKG Watch orders, initiate communication with the docking station and access PKG reports. The PKG 
Portal may also be used by patients to track symptoms, mood and activities of daily living such as 
exercise, work and social activities during each day the PKG Watch is worn.  
 
PKG Report 
At the end of the recording period, data are downloaded and analyzed using proprietary 
algorithms to translate raw movement data collected by the PKG Watch into clinically 
meaningful results. This output is called a “PKG.” The maximum acceleration in each 2-minute 
epoch is identified and the mean spectral power surrounding this peak is calculated. Algorithms 
produce Bradykinesia Scores (BKS) and Dyskinesia Scores (DKS) every two minutes. The PKG 
includes, but is not limited to: 
• a scaled record of a dyskinesia score (DKS) representative of dyskinesia plotted against 
time of day for individual days over the full recording period (Figure 2).  
• a scaled record of a bradykinesia score (BKS) representative of bradykinesia plotted 
against time of day for individual days over the full recording period (Figure 2).  
• a record of periods of immobility, which may be indicative of periods of daytime sleep 
and somnolence, plotted against time of day.  
• a record of periods when the patient was not wearing the PKG Watch or when it was 
‘off-wrist’.  
• a record of the patient’s self-reported compliance with their prescribed program of 
Parkinson’s disease medication.  
• a record of periods of tremor for each day and a tremor summary. 
 
 

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         Figure 2: PKG 
 
 
4. STUDY DESIGN 
This is a prospective, multi-center, observational research study of the PKG System in patients 
who are eligible based on the inclusion/exclusion criteria.  The clinical validation will require 
recruitment of both subjects with a diagnosis of a movement disorder such as Parkinson’s 
disease and healthy control subjects who do not have any other neurological disorders that 
would interfere with data collection.  Up to 500 total subjects at up to 2 sites will be enrolled 
including these two subject profiles.  Subjects will be evaluated based on eligibility criteria and 
data will be collected on study-specific case report forms.  
 
Subjects will be evaluated at a screening visit to confirm they are able to complete the required 
tasks.  
 
 
Table of Assessments: 
Activities 
Screening 
Clinic or Telehealth 
Visit 
Subject PKG 
Watch Wear 
Follow-up Visit** 

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Informed Consent 
(MD) 
X 
 
 
Subject Screening Criteria & Enrollment 
(MD) 
X 
 
 
Demographics & Medical History 
(Coordinator) 
X 
 
 
*Order PKG Watch for extended PKG Watch 
Wear 
(Coordinator) 
X 
 
 
In-clinic validation tests (video, MDS-
UPDRS, ePROs, etc.) 
X 
 
 
In-clinic PKG Watch Wear (bi-lateral or 
unilateral) 
X 
 
 
*PKG Watch Extended Wear (bi-lateral or 
unilateral) 
 
(GK fulfillment) 
 
X 
 
*At-home Assessments (surveys, ePROs, 
diary, etc. by subject or caregiver) 
 
X 
 
*Activity Log  
 
X 
 
Product usability and satisfaction 
questionnaires 
 
X 
 
*Review of patient assessments  
 
 
X 
*May be repeated if unable to provide at least 5 full, continuous days of PKG data for each watch  
** May be performed at clinic, via telehealth visit or phone call per institutional standards 
 
 
5. SCREENING VISIT 
Informed Consent Process 
Subjects will be identified and pre-screened from routine clinical care if the Study PI feels the 
patient would be eligible for this study. 
 
Informed Consent Procedure:  A potential participant is identified and the Study PI has a 
conversation about the study.  If the subject is eligible for enrollment and is interested in 
participating the consent process will take place in the office where the patient will have ample 
time to decide if they want to proceed.  If the subject needs more time to consider, they will be 
sent home with study information and an informed consent form. Instructions will be provided 
to mail the signed and dated consent form back to the Study PI in a pre-stamped envelope or 
per clinic institutional IRB approved procedure.  
 
Subject Screening Criteria 

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A study investigator will assess each subject’s candidacy for the study based on the following 
subject screening criteria: 
 
Inclusion Criteria - Study subjects must fulfill the following criteria: 
• Able and willing to sign a written informed consent for study participation 
• Age ≥18 years old Existing diagnosis of a movement disorder or a healthy control subject 
without diagnosis of a movement disorder 
Exclusion Criteria – Subjects with any of the following clinical criteria will be excluded: 
• Bedridden, wheelchair confined, or requires the regular use of an assistive gait device 
(e.g., walker, cane, etc.)  
• Occupation that involves repetitive movement or complete immobility (e.g., janitor, 
construction, or sedentary with no/limited arm movements such as a taxi driver) 
• In the investigator’s or sponsor’s opinion, subject has any unstable or clinically 
significant condition that would impair the participant’s ability to complete the required 
PKG watch wear (e.g., subject unable to complete PKG wear instructions per Patient 
Instruction Manual), complete required assessments or interfere with data collection. 
 
Enrollment Criteria 
Subjects will be considered screen failures if they do not meet study selection criteria. Subjects 
who meet all study selection criteria and have documented written informed consent on file 
will be considered enrolled and continue in the study.  
 
In-Clinic Validation Testing 
The Study PI will determine the required validation testing for each subject based upon the 
validation measure being tested.  Subjects may receive video assessment of them walking or 
performing certain tasks while wearing the PKG Watch or PKG Watches (1 watch on each wrist). 
Subjects may also receive movement disorder related assessments such as Movement 
Disorders Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Hoehn and Yahr scale (H&Y), 
Parkinson’s Disease Questionnaire (PDQ-39), Non-Motor Questionnaire (NMSQuest), Freezing 
of Gait Questionnaire (FOG-Q), The Essential Tremor Rating Assessment Scale (TETRAS), 
Epworth Sleepiness Scale (ESS), Parkinson’s Disease Sleep Scale (PDSS), the Montreal Cognitive 
Assessment (MoCA) and/ or other electronic patient/clinician/observer/performance reported 
outcomes (ePRO/ClinRO/ObsRO/PerfO) during this visit including EQ-5D, patient diaries.  Each 
procedure and assessment will be explained to the subject upon enrollment into the study.  
 
PKG Watch for In-Clinic Wear 

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The study coordinator will have a supply of PKG Watches and docking station available to use 
for an in-office assessment requiring recording on the PKG Watch and other in-office 
assessments to be completed simultaneously.  The study coordinator will program the PKG 
Watch for the subject and assist with the fitting.  The subject will wear the PKG Watch or PKG 
Watches (1 watch on each wrist) only for the required in-office testing and leave the PKG 
Watch(es) with the study coordinator at the end of the visit. The study coordinator will upload 
the data from the PKG Watch(es).  The PKG Watch(es) will be reprogrammed for each subject 
requiring an in-clinic wear. 
 
PKG Watch Administration for Extended Wear 
After the Screening Visit, the study coordinator will order the required PKG System per subject 
enrolled as required. Upon receiving approval from site (this can only occur after a fully 
executed consent has been verified by the study coordinator), Global Kinetics (GK) Fulfillment 
Staff may contact the subject to explain PKG System use, and dispense the PKG System to the 
subject with a copy of the Patient Instruction Manual.  The subject may contact the study site 
and/or GK Fulfillment Staff with any questions regarding the PKG System.  
 
Concurrent with the PKG Watch wear for extended use, the subject may complete an activity 
journal of all movements throughout the day and a diary.  The activity journal and diary  will 
include recording of activities such as routine exercise like walking or jogging, outside of day-to-
day living activities, sleep, medication times, falls, mood, symptoms. In addition, the subject 
may complete PKG questionnaires regarding their experience and usability of the product. The 
subject will complete the activity journal, diary and/or questionnaires via ePRO or sign and 
return the forms to the investigator using the provided stamped, addressed envelope via US 
mail.  
 
For each cohort (PKG Score) that will be enrolled, Sponsor will indicate to clinical trial site and 
provide training on the procedures relevant to assessments associated with that cohort. 
Therefore, refer to the study Manual of Operations for detailed instructions for each 
assessment required, for each cohort that is being assessed, which will include procedures 
required for each cohort. Details on video recording and tasks to be completed (e.g., carrying a 
jug of water) will be detailed in the Manual of Operations.  
 
6. FOLLOW-UP VISIT 
Once the subject has completed a prescribed wear period indicated by the clinic staff, the 
subject will return the PKG Watch(es) to GK Fulfillment Staff using the provided stamped, 
addressed envelope via US mail. The study staff will contact the subject via phone to inform 
them whether or not they have successfully completed the study.  The study staff may also ask 

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the subject if they had any issues using the PKG System.  If, for any reason, the subject is unable 
to wear the PKG Watch(es) for the prescribed period and per instructions provided, the subject 
may be asked to complete another wear period by the clinic staff. The subject or caregiver will 
also be asked to complete another activity journal, surveys and/or ePROs as indicated during 
the additional wear period.  
 
7. STUDY ENDPOINTS 
 
Primary Endpoint: 
Evaluation of new PKG assessments to be clinically validated including but not limited to 
gait/walking, Device Assisted Therapy readiness, Percent Time Bradykinesia (PTB), Percent Time 
Dyskinesia (PTD), fall prediction, disease progression and non-motor symptoms. 
The primary endpoint evaluation for the validation of the new PKG measures will include 
standard calculations including correlation, point in time measurement compared to diaries and 
activity logs, change in PKG scores from beginning of recording to end of recording period, 
comparison of results between movement disorder patient recordings and those from healthy 
volunteer recordings to detect movement associated with movement disorder subjects 
compared to healthy volunteer subjects. 
Secondary Endpoints: 
Secondary clinical outcomes of interest will include but will not be limited to: 
• Evaluation of PKG scores including BKS, DKS, PTT, FDS and PTI on healthy control 
subjects (non-PD; healthy control) to assess differences by age category.  
o PKG measurements will be recorded and compared across age ranges  for 
subjects enrolled. Age categories of 18-40, from 40-59 years old, 60-79 years old, 
80-90 years old and > 90 years old will be evaluated. This will provide a 
representative sample of subjects with early onset (<60 years), average age (60-
79 years) and older subjects (80-90 years) with movement disorders.  
• Comparison of PKG scores to standard PD assessments such as MDS-UPDRS, H&Y, 
PDQ39, FOG-Q, TETRAS, diaries  
• Comparison of PKG scores to standard non-motor assessment such as NMSQuest 
• Comparison of PKG scores to sleep assessments such as ESS and PDSS 
• Comparison of PKG scores to MoCA 
• Comparison of PKG scores to standard quality of life measurements such as EQ-5D 
• Evaluation of product usability and satisfaction for PKG Watch, docking station and the 
PKG Portal   
 
8. STATISTICS 

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Due to the nature of this research study, no formal hypothesis will be proposed, nor will a 
formal statistical analysis be conducted.  Rather, this study will examine outcomes of each case 
and be descriptive in nature. 
 
9. INVESTIGATOR QUALIFICATIONS 
Physicians participating in this study must be able to conduct an assessment of clinical diagnosis 
to confirm subject either has a diagnosis of a movement disorder or is a healthy control subject. 
For the healthy control population, investigator will confirm the subject does not have other 
neurological disease(s) that would interfere with data collection and analysis. 
 
10. INSTITUTIONAL REVIEW BOARD 
Each site is required to have Institutional Review Board (IRB) approval prior to starting this 
study and throughout the course of study conduct. Each site will maintain IRB correspondence 
including written initial and ongoing IRB approvals. 
 
11. PROTOCOL DEVIATIONS 
A protocol deviation is defined as a circumstance in which the study investigator, site personnel 
or subject did not conduct the study according to the requirements of the study protocol. 
Protocol deviations will be documented on the Protocol Deviation CRF and are to be reported 
per IRB requirements. 
 
12. BENEFIT/RISK ANALYSIS 
Results from this study are expected to contribute to the objective evaluation of movement in 
subjects with PD against a standardized control dataset.  
The PKG Movement Recording System and this study present no more than minimal risk to 
study subjects resulting in a minimal risk determination based on the PKG Movement Recording 
System, its use in this study, and the following criteria: 
• 
Are not intended as an implant and present a potential for serious risk to the health, 
safety, or welfare of a subject; 
• Are not purported or represented to be for use supporting or sustaining human life and 
presents a potential for serious risk to the health, safety, or welfare of a subject; 
• Are not for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and presents a potential 
for serious risk to the health, safety, or welfare of a subject.  
Adverse events and risks associated with this study are similar to those normally associated 
with standard clinical care of subjects with PD who wear the PKG watch; thus, additional 

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adverse events are not anticipated. Current product safety information, including 
contraindications, warnings, and precautions, are located in the Patient Instructions Manual 
and Clinical Interpretation Guide.  
Although not anticipated, Unanticipated Adverse Device Effect (UADE) will be reported in 
accordance with 21 CFR 812.150 starting at the point of enrollment for all subjects enrolled into 
the study. A UADE is defined as any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application, or any other unanticipated serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects.  
Additionally, any complaints regarding any component of the PKG Movement Recording System 
will be reported to GK and processed per GK’s standard post-market surveillance processes and 
any adverse events associated with the use of the PKG Movement Recording System will be 
summarized in the final report for this study. 
 
 
 
 

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https://www.movementdisorders.org/MDS/Education/Workshops-Conferences/Virtual-
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2. Understanding Parkinson’s Disease? Parkinson’s Disease Foundation. Retrieved November 
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3. Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations 
as estimated from the cumulative literature. Mov Disord. 2001;16(3):448-58. PubMed 
PMID: 11391738.  
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