- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251701
Personal KinetiGraph® Clinical Validation Study
March 2, 2023 updated by: Global Kinetics Corporation
The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, observational research study of the Personal KinetiGraph (PKG) System.
The PKG System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
This study aims to clinically validate new PKG assessments such as walking, Device Assisted Therapy readiness, Percent Time Bradykinesia, Percent Time Dyskinesia, fall prediction, disease progression and non-motor.
The clinical validation will require enrollment of both subjects with a diagnosis of movement disorder, such as Parkinson's disease, and healthy control subjects who do not a neurological disorder.
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen Krygier, MBA
- Phone Number: 612.240.2437
- Email: karen.krygier@globalkineticscorp.com
Study Contact Backup
- Name: Kristin Johnson
- Phone Number: 701.331.2183
- Email: kristin.johnson@globalkineticscorp.com
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85710
- Recruiting
- Tucson Neuroscience Research
-
Contact:
- Diana Benenati, Dr.
-
Principal Investigator:
- Diana Benenati
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be identified from routine clinical care
Description
Inclusion Criteria:
- Able and willing to sign a written informed consent for study participation
- Existing diagnosis of a movement disorder or a healthy control subject without diagnosis of a movement disorder
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch
Time Frame: 2-3 years
|
The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
|
2-3 years
|
Evaluation of new PKG assessments to be clinically validated for Device Assisted Therapy readiness using movement data collected from the PKG Watch
Time Frame: 2-3 years
|
For this outcome, patients may be classified as Device Assisted Therapy (DAT) criteria positive or criteria negative.
DAT readiness may be evaluated using the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts.
Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6.
Each score ranges from 0 (normal) to 4 (severe).
Higher scores indicate a greater impact of Parkinson's disease symptoms.
PKG measurements may be compared to the patient's clinical characteristics and MDS-UPDRS scores.
|
2-3 years
|
Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB)
Time Frame: 2-3 years
|
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39).
The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts.
Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6.
Each score ranges from 0 (normal) to 4 (severe).
Higher scores indicate a greater impact of Parkinson's disease symptoms.
The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life.
Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
|
2-3 years
|
Evaluation of new PKG assessments to be clinically validated for Percent Time Dyskinesia (PTD) using movement data collected from the PKG Watch
Time Frame: 2-3 years
|
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39).
The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts.
Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6.
Each score ranges from 0 (normal) to 4 (severe).
Higher scores indicate a greater impact of Parkinson's disease symptoms.
The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life.
Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
|
2-3 years
|
Evaluation of new PKG assessments to be clinically validated for fall prediction using movement data collected from the PKG Watch
Time Frame: 2-3 years
|
PKG measurements may be compared to data collected from freezing of gait questionnaire (FOG-Q) and posture analysis.
The FOG-Q assesses freezing of gait severity and consists of 4 questions, each scored from 0-4.
Higher scores indicates more severe freezing of gait.
Step count performance may also be used to evaluate fall prediction.
The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
|
2-3 years
|
Evaluation of new PKG assessments to be clinically validated for disease progression using movement data collected from the PKG Watch
Time Frame: 2-3 years
|
Disease progression may be evaluated by predicting the levodopa response using severity levels of the Bradykinesia Score (BKS) and early morning Bradykinesia.
Changes in PKG measurements may be compared to the MDS-UPDRS which evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts.
Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6.
Each score ranges from 0 (normal) to 4 (severe).
Higher scores indicate a greater impact of Parkinson's disease symptoms.
|
2-3 years
|
Evaluation of new PKG assessments to be clinically validated for non-motor outcomes using non-motor scales
Time Frame: 2-3 years
|
PKG system data may be compared to non-motor assessments such as the non-motor questionnaire (NMSQ).
The NMSQ includes questions regarding non-motor symptoms such as difficulty swallowing, constipation, difficulty sleeping, cognition, mood.
Higher scores indicate more non-motor symptoms.
|
2-3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of PKG scores to assess differences by age category
Time Frame: 2-3 years
|
PKG measurements will be recorded and compared across age ranges (40-90 years old as defined in the Inclusion Criteria) for subjects enrolled.
Age categories from 40-59 years old, 60-79 years old and 80-90 years old will be evaluated.
|
2-3 years
|
To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale
Time Frame: 2-3 years
|
The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts.
Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6.
Each score ranges from 0 (normal) to 4 (severe).
Higher scores indicate a greater impact of Parkinson's disease symptoms.
|
2-3 years
|
To compare PKG scores to standard Parkinson's disease assessments such as Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: 2-3 years
|
The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life.
Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
|
2-3 years
|
To compare PKG scores to standard Parkinson's disease assessments such as the Freezing of Gait Questionnaire (FOG-Q)
Time Frame: 2-3 years
|
The FOG-Q assesses freezing of gait severity and consists of 4 questions, each scored from 0-4.
Higher scores indicates more severe freezing of gait.
|
2-3 years
|
To compare PKG scores to standard Parkinson's disease assessments such as The Essential Tremor Rating Assessment Scale (TETRAS)
Time Frame: 2-3 years
|
TETRAS assesses essential tremor severity and its impact on activities of daily living (ADL).
The ADL section includes 12 items and the performance section includes 9.
Each item is rated 0-4.
Higher scores indicate more severe impacts of ADL and tremor.
|
2-3 years
|
To compare PKG scores to subject diaries
Time Frame: 2-3 years
|
Subject diaries will include recordings of medication times, falls, symptoms and sleep.
|
2-3 years
|
To compare PKG scores to non-motor assessments such as the Non-Motor Symptoms Questionnaire (NMSQ)
Time Frame: 2-3 years
|
The NMSQ includes 30 questions, answered either yes or no, and assesses the presence, not severity, of non-motor symptoms.
|
2-3 years
|
To compare PKG scores to sleep assessments such as Epworth Sleepiness Scale (ESS) and Parkinson's Disease Sleep Scale (PDSS)
Time Frame: 2-3 years
|
The ESS includes 8 questions each scored from 0-3 with a maximum score of 24. The higher the ESS score, the higher that person's average sleep propensity or 'daytime sleepiness'. The PDSS includes 15 questions, each rated from 0 to 10, with 0 being "Awful" or "Always" and 10 being "Excellent" or "Never". |
2-3 years
|
To compare PKG scores to the Montreal Cognitive Assessment (MoCA)
Time Frame: 2-3 years
|
The MoCA is an assessment used for detecting cognitive impairment.
The scores range from 0 to 30 with 0 being the lowest and 30 being the highest.
|
2-3 years
|
To compare PKG scores to quality of life measurements such as EuroQual 5-D (EQ-5D)
Time Frame: 2-3 years
|
The EQ-5D assesses health-related quality of life.
Each question is scored from either 1-3 or 1-5, with 1 indicating no problems and 3 or 5 indicating extreme problems.
|
2-3 years
|
To evaluate product usability and satisfaction for PKG Watch, docking station and PKG Portal
Time Frame: 2-3 years
|
PKG product usability and satisfaction questionnaires will be used to evaluate this outcome.
Responses to questions range from very difficult to very easy, strongly disagree to strongly agree, very uncomfortable to very comfortable.
|
2-3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zoltan Mari, MD, Z Neurosciences, LLC.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
- Griffiths RI, Kotschet K, Arfon S, Xu ZM, Johnson W, Drago J, Evans A, Kempster P, Raghav S, Horne MK. Automated assessment of bradykinesia and dyskinesia in Parkinson's disease. J Parkinsons Dis. 2012;2(1):47-55. doi: 10.3233/JPD-2012-11071.
- Kotschet K, Johnson W, McGregor S, Kettlewell J, Kyoong A, O'Driscoll DM, Turton AR, Griffiths RI, Horne MK. Daytime sleep in Parkinson's disease measured by episodes of immobility. Parkinsonism Relat Disord. 2014 Jun;20(6):578-83. doi: 10.1016/j.parkreldis.2014.02.011. Epub 2014 Feb 24.
- Braybrook M, O'Connor S, Churchward P, Perera T, Farzanehfar P, Horne M. An Ambulatory Tremor Score for Parkinson's Disease. J Parkinsons Dis. 2016 Oct 19;6(4):723-731. doi: 10.3233/JPD-160898.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2022
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
January 1, 2025
Study Registration Dates
First Submitted
October 29, 2021
First Submitted That Met QC Criteria
February 11, 2022
First Posted (Actual)
February 23, 2022
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 2, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study 006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Any clinical study IPD may be made available to other researchers including PKG data; demographics, such as age, gender, ethnicity; medical history, such as comorbid conditions and movement disorder history.
Subject data will not include any personally identifiable information.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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