Parkinson DiseaseTARGET-PDNCT03984305
Utilization of Target Ranges to Treat Parkinson's Disease With the PKG
A study testing Personal KinetiGraph® (PKG®) Watch and Personal KinetiGraph® (PKG®) Report in people with Parkinson Disease, run by Global Kinetics Corporation at 17 sites in United States.
Trial summary
The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological… Read more about this study
- Who is it for?
- Ages 46 to 83 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Personal KinetiGraph® (PKG®) Watch and Personal KinetiGraph® (PKG®) Report
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 17 sitesUnited States
- Study dates
- 15 Oct 2019to 16 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to sign a written informed consent for study participation
- Presumed to have Levodopa responsive idiopathic Parkinson's Disease
- Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
- Has not been previously managed with the PKG
Who cannot join
- Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
- MoCA score <23 at screening visit
- Diagnosis of Essential Tremor
- Wheelchair bound or bedridden
- Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
- In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject unable to complete PKG watch wear instructions per Patient Instruction Manual)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, 11725
Michigan State University
East Lansing, Michigan, 48824
Washington Regional Medical Center
Fayetteville, Arkansas, 72703
Neurology Center of New England
Foxborough, Massachusetts, 02035
University of Florida
Gainesville, Florida, 32608
University of Texas
Houston, Texas, 77030
Marshall University
Huntington, West Virginia, 25701
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
Parkinson's Disease and Movement Disorders Center of Silicon Valley
Menlo Park, California, 94025
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Weill Cornell
New York, New York, 10021
University of Nebraska
Omaha, Nebraska, 68198
Kaiser Mid-Atlantic Permanente Center
Rockville, Maryland, 20852
University of South Florida
Tampa, Florida, 33612
About this study
Official title: Utilization of Target Ranges to Treat Patients With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial
The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).
Read the detailed description
This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).
- Conditions
- Parkinson Disease
- Being tested
- Personal KinetiGraph® (PKG®) Watch, Personal KinetiGraph® (PKG®) Report
- Keywords
- Personal KinetiGraph (PKG) Movement Recording System, Objective Measurement
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal KinetiGraph® (PKG®) WatchDevice
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®) ReportDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PKG+ Group | Experimental | 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. Receives: Device: Personal KinetiGraph® (PKG®) Watch; Device: Personal KinetiGraph® (PKG®) Report |
| PKG- Group | Placebo comparator | 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. Receives: Device: Personal KinetiGraph® (PKG®) Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Secondary outcomes (13)
Percentage of Responders for Total MDS-UPDRS
Percent "responders" for total MDS-UPDRS based on a minimal clinically important change of 4.3 (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.)
Measured: 4 month Follow-up Visit
Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39)
Change in the patient reported quality of life questionnaire PDQ-39 from Baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in MDS-UPDRS Total From Baseline
The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Measured: From Baseline to the 1, 2 and 3-Year Annual Visits
Change in MDS-UPDRS Sub Part I
Change in sub part I of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part I assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part I is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Bradykinesia Score (BKS)
Change in the PKG reported scores BKS from baseline. Reported on a scale from 0-80. The higher the number, the more severe the bradykinesia.
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Dyskinesia Score (DKS)
Change in the PKG reported scores DKS from baseline. Reported on a scale of 0-355 with the higher the score, the more severe the dyskinesia.
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Fluctuation Score (FDS)
Change in the PKG reported scores FDS from baseline reported as a score of 0-45. The higher the score, the more severe the fluctuation.
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Percent Time Tremor (PTT)
Change in the PKG reported percent time in tremor from baseline, max 100%
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in Levodopa Equivalent Dose (LED)
Change in LED from baseline to 4-months
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
PKG Patient Survey
Analyze PKG usability with the PKG Patient reported survey, specifically the percentage of subjects that strongly agree when asked if they would be willing to use the PKG again to assist in the management of Parkinson's disease. Questions in the survey are on a scale of strongly agree to strongly disagree and will be patient reported information related to their use of the PKG watch. Both treatment groups will be administered the survey and scores will be aggregated by group and compared.
Measured: Outcome measure evaluated at the 4-month Follow-up Visit
Change in MDS-UPDRS Sub Part II
Change in sub part II of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part II assesses the non-motor impact of Parkinson's disease and contains 13 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part II is 0 and the maximum score is 52. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in MDS-UPDRS Sub Part III
Change in sub part III of the MDS-UPDRS from baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part III assesses the motor impact of Parkinson's disease and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part III is 0 and the maximum score is 132. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Measured: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in MDS-UPDRS Sub Part IV
Change in Part IV of the MDS-UPDRS from Baseline. The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and contains 4 sub parts. Each sub part is summed to give a total score MDS-UPDRS score. Sub part IV evaluates motor symptoms and contains 6 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). The minimum score for this sub part IV is 0 and the maximum score is 24. Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Measured: From Baseline to the 4-month Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start15 Oct 2019
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Why it stopped: Terminated due to significant protocol updates that resulted in initiating a new study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Kinetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raja Mehanna, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984305
- Sponsor's protocol ID
- Study 003
- Acronym
- TARGET-PD
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2019
- Last updated
- 8 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.
PubMed 30032695Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.
PubMed 20065131
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Target Ranges to Treat Patients With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03984305
- Acronym / sponsor ID
- TARGET-PD / Study 003
- Conditions
- Parkinson Disease
- Keywords
- Personal KinetiGraph (PKG) Movement Recording System, Objective Measurement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to significant protocol updates that resulted in initiating a new study
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Global Kinetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Posted 8 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).
Detailed description
This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).
| Arm | Type | Receives |
|---|---|---|
| PKG+ Group | Experimental | Device: Personal KinetiGraph® (PKG®) Watch, Device: Personal KinetiGraph® (PKG®) ReportFor 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. |
| PKG- Group | Placebo comparator | Device: Personal KinetiGraph® (PKG®) WatchFor 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. |
Who may qualify
- Ages
- 46 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to sign a written informed consent for study participation
- Presumed to have Levodopa responsive idiopathic Parkinson's Disease
- Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
- Has not been previously managed with the PKG
Key exclusion criteria (6 listed)
- Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
- MoCA score <23 at screening visit
- Diagnosis of Essential Tremor
- Wheelchair bound or bedridden
- Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal KinetiGraph® (PKG®) WatchThe 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. | Device | PKG+ Group, PKG- Group |
| Personal KinetiGraph® (PKG®) ReportThe 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. | Device | PKG+ Group |
Primary outcome
Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
13 secondary outcomes
Percentage of Responders for Total MDS-UPDRS
Time frame: 4 month Follow-up Visit
Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39)
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in MDS-UPDRS Total From Baseline
Time frame: From Baseline to the 1, 2 and 3-Year Annual Visits
Change in MDS-UPDRS Sub Part I
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Bradykinesia Score (BKS)
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Dyskinesia Score (DKS)
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Fluctuation Score (FDS)
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in PKG Percent Time Tremor (PTT)
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in Levodopa Equivalent Dose (LED)
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
PKG Patient Survey
Time frame: Outcome measure evaluated at the 4-month Follow-up Visit
Change in MDS-UPDRS Sub Part II
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in MDS-UPDRS Sub Part III
Time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
Change in MDS-UPDRS Sub Part IV
Time frame: From Baseline to the 4-month Follow-up Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30032695Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.
- Background: PubMed 20065131Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Mehanna, MD principal investigator
The University of Texas Health Science Center, Houston
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal KinetiGraph® (PKG®) Watch and Personal KinetiGraph® (PKG®) Report in people with Parkinson Disease, run by Global Kinetics Corporation at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.