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The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personal KinetiGraph® (PKG®) System | Device | The PKG® System includes a wrist-worn device that records and measures movement patterns in conditions such as Parkinson's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch | 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 | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of PKG scores to assess differences by age category | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be identified from routine clinical care
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| Name | Affiliation | Role |
|---|---|---|
| Zoltan Mari, MD | Z Neurosciences, LLC. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Neuroscience Research | Tucson | Arizona | 85710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23939408 | Background | 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. | |
| 25928634 | Background | 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. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2022 | Sep 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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 | 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 | 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 | 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 |
| To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale |
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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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 |
| 24674770 | Background | 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. |
| 27589540 | Background | 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. |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |