Parkinson DiseaseNCT05153356
A Prospective Longitudinal Assessment of PD Functional Impairment and Disability Via Mobile Health Technology
An observational study of Parkinson Disease, run by Rush University Medical Center.
Trial summary
The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in Parkinson's disease patients. Read more about this study
- Who is it for?
- Ages 35 to 68 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Personal Kinetigraph, Kinesia 360
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients with Parkinson Disease who are currently on levodopa treatment will be included in the study cohort. They must meet the inclusion/exclusion criteria.
Who may be able to join
- PD as defined by the UK Brain Bank Criteria
- Disease duration between 2-13 years
- Aged 35-68 years
- Hoehn \& Yahr stage 3 or less when in the levodopa-"ON" state
Who cannot join
- Atypical parkinsonism including 18F-dopa PET patterns consistent with this
- MMSE score of < 24 or evidence for dementia using DSM-IV criteria
- Unable to do normal copying of interlocking pentagons and semantic fluency score <20 over 90 secs
- Ongoing major medical or psychiatric disorder including depression and psychosis
- Other concomitant treatment with neuroleptics
- Significant drug induced dyskinesias (>2 for any body part on the AIMS scale)
- Previous neurosurgery Unable to be imaged using MRI
About this study
Official title: A Prospective Longitudinal Assessment of Parkinson's Disease Functional Impairment and Disability Via Mobile Health Technology
The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in Parkinson's disease patients.
Read the detailed description
Mobile health technologies include the wearable sensor technologies that are body-worn and passively collect information and mobile devices like smartphones that can be frequently used by patients to actively or passively collect information. However, there has been limited comparison of different wearable technologies to validated clinical rating scales to allow us to come to a consensus about their utility in both clinical practice and research trials. Data from mobile health technologies in Parkinson's Disease (PD) have not been validated to use in the place of clinician rating scales. It is also not clear if the information obtained with the devices consistently correlates with change on the clinician scales and longitudinal motor decline. Technological challenges, such as the feasibility (safety, compliance) of use devices in patients with neurodegenerative disease, change in equipment and algorithms over time, collaboration with companies who may own patents, and other issues may also limit their use in healthcare and research. The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in PD patients. The hypothesis is that there will be an association between data from mobile health technologies and data obtained from validated questionnaires/scales, indicating that these technologies are a reliable means of monitoring motor symptomatology and functional impairment and disability over time. The primary aims of the study are to compare information on continuously-measured patient-reported PD-related functional impairment and disability changes from traditional validated questionnaires to continuously-measured health-related data from a battery of novel mobile health technologies, and to assess the feasibility (compliance, safety, satisfaction) of PD patients to use a battery of novel mobile health technologies.
- Conditions
- Parkinson Disease
- Being tested
- Personal Kinetigraph, Kinesia 360
- 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, Kinesia 360Device
10 patients will be assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease patients | To examine the relationship between in-home continuous measures of tremor, bradykinesia, mobility, and dyskinesia acquired over a 7-day period, from 2 mobile health technologies (Personal Kinetigraph, Kinesia 360) with one-time in-clinic measures of motor functional ability pertaining to the same 7-day period as assessed by Part 2 of the MDS-UPDRS, Part 4 of the MDS-UPDRS, Neuro-QOL, and PDQ-39. This will be examined in n=20 patients (10 patients assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks). Patients will then be following for an observational period of an additional 6 months. Receives: Device: Personal Kinetigraph, Kinesia 360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Kinetigraph
Watch containing accelerometer and gyroscope for measurement of motor symptoms of PD
Measured: 3 months
Kinesia 360
2 sensor straps to wrist and ankle containing accelerometer and gyroscope for measurement of motor symptoms of PD.
Measured: 3 months
MDS-UPDRS
Part I assesses the non-motor aspects of experiences of daily living in the week prior to the visit. Part II assesses the motor aspects of experiences of daily living in the week prior to the visit. Part III assesses motor disabilities of a subject at the time of the visit and Part IV assesses motor complications in the week prior to the visit. A total of 46 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Jun 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: The P.I decided not to move forward with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah A Hall, MD,PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153356
- Sponsor's protocol ID
- 20100709
- Status last verified
- Jul 2023
- First submitted
- 29 Nov 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Assessment of Parkinson's Disease Functional Impairment and Disability Via Mobile Health Technology
- ClinicalTrials.gov ID
- NCT05153356
- Acronym / sponsor ID
- 20100709
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The P.I decided not to move forward with the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in Parkinson's disease patients.
Detailed description
Mobile health technologies include the wearable sensor technologies that are body-worn and passively collect information and mobile devices like smartphones that can be frequently used by patients to actively or passively collect information. However, there has been limited comparison of different wearable technologies to validated clinical rating scales to allow us to come to a consensus about their utility in both clinical practice and research trials. Data from mobile health technologies in Parkinson's Disease (PD) have not been validated to use in the place of clinician rating scales. It is also not clear if the information obtained with the devices consistently correlates with change on the clinician scales and longitudinal motor decline. Technological challenges, such as the feasibility (safety, compliance) of use devices in patients with neurodegenerative disease, change in equipment and algorithms over time, collaboration with companies who may own patents, and other issues may also limit their use in healthcare and research. The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in PD patients. The hypothesis is that there will be an association between data from mobile health technologies and data obtained from validated questionnaires/scales, indicating that these technologies are a reliable means of monitoring motor symptomatology and functional impairment and disability over time. The primary aims of the study are to compare information on continuously-measured patient-reported PD-related functional impairment and disability changes from traditional validated questionnaires to continuously-measured health-related data from a battery of novel mobile health technologies, and to assess the feasibility (compliance, safety, satisfaction) of PD patients to use a battery of novel mobile health technologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease patients | – | Device: Personal Kinetigraph, Kinesia 360To examine the relationship between in-home continuous measures of tremor, bradykinesia, mobility, and dyskinesia acquired over a 7-day period, from 2 mobile health technologies (Personal Kinetigraph, Kinesia 360) with one-time in-clinic measures of motor functional ability pertaining to the same 7-day period as assessed by Part 2 of the MDS-UPDRS, Part 4 of the MDS-UPDRS, Neuro-QOL, and PDQ-39. This will be examined in n=20 patients (10 patients assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks). Patients will then be following for an observational period of an additional 6 months. |
Who may qualify
- Ages
- 35 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with Parkinson Disease who are currently on levodopa treatment will be included in the study cohort. They must meet the inclusion/exclusion criteria.
Key inclusion criteria (4 listed)
- PD as defined by the UK Brain Bank Criteria
- Disease duration between 2-13 years
- Aged 35-68 years
- Hoehn \& Yahr stage 3 or less when in the levodopa-"ON" state
Key exclusion criteria (7 listed)
- Atypical parkinsonism including 18F-dopa PET patterns consistent with this
- MMSE score of < 24 or evidence for dementia using DSM-IV criteria
- Unable to do normal copying of interlocking pentagons and semantic fluency score <20 over 90 secs
- Ongoing major medical or psychiatric disorder including depression and psychosis
- Other concomitant treatment with neuroleptics
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, Kinesia 36010 patients will be assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks. | Device | Parkinson Disease patients |
Primary outcome
Personal Kinetigraph
Time frame: 3 months
Watch containing accelerometer and gyroscope for measurement of motor symptoms of PD
Kinesia 360
Time frame: 3 months
2 sensor straps to wrist and ankle containing accelerometer and gyroscope for measurement of motor symptoms of PD.
MDS-UPDRS
Time frame: 6 months
Part I assesses the non-motor aspects of experiences of daily living in the week prior to the visit. Part II assesses the motor aspects of experiences of daily living in the week prior to the visit. Part III assesses motor disabilities of a subject at the time of the visit and Part IV assesses motor complications in the week prior to the visit. A total of 46 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Deborah A Hall, MD,PhD principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Rush University Medical Center.
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 7 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: withdrawn, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Personal Kinetigraph (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2023.