Parkinson DiseaseNCT05247294
Assessment of Fluctuating Parkinson's Disease With Sensor-based Home Monitoring
An observational study of Parkinson Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to implement home-based monitoring (HBM) using remote-capture wearable devices and patient reported outcomes (PROs) in a rather homogeneous subgroup of advanced Parkinson's Disease (PD) patients, suffering from significant motor fluctuations (MF) and Levodopa-induced dyskinesia (LID), over a… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Nov 2019to 24 Feb 2021
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced Parkinson's Disease (PD) patients, suffering from significant motor fluctuations (MF) and Levodopa-induced dyskinesia (LID)
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease for at least 5 years
- Males or females over the age of 30
- Patients treated with oral levodopa (3 daily doses or more), reporting motor fluctuations and (preferably) with l-dopa-induced dyskinesia
- UPDRS-MDS 4.4 functional impact of fluctuations (mild + severe, 2-4)
- Hoehn \&Yahr stage 1-3 while ON
- Ability to operate smartphone technology in the household
- Mini-Mental State Examination score >20
Who cannot join
- Cognitive or psychiatric impairment that would preclude study participation as determined by the principal investigator
- Additional major comorbidities
- Levodopa-resistant tremor (tremor during ON)
- Levodopa-resistant freezing (freezing during ON)
- Previous surgical treatment for PD
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to implement home-based monitoring (HBM) using remote-capture wearable devices and patient reported outcomes (PROs) in a rather homogeneous subgroup of advanced Parkinson's Disease (PD) patients, suffering from significant motor fluctuations (MF) and Levodopa-induced dyskinesia (LID), over a two-week period.
The investigators aim to provide a more comprehensive picture of patient symptoms, severity, and fluctuations and compare these data to interview-derived clinical data.
Read the detailed description
Parkinson's Disease (PD) is a neuro-degenerative disorder affecting millions of people worldwide. PD is associated with both motor and non-motor symptoms that affect patients' functioning and Quality of life.
The motor symptoms consist of tremor, rigidity, bradykinesia and gait impairments. Additional important motor symptoms that are associated with chronic Levodopa therapy, are levodopa-induced dyskinesia and motor fluctuations.
Currently, the accepted clinical measurement of PD symptom severity is the Movement Disorders Society-unified Parkinson's disease rating scale (MDS-UPDRS), which is based, in part, on subjective and potentially recall-based reports by the patients and on semi-objective observations by the clinician.
On average, PD patients see their treating neurologist for in-clinic visits twice a year. These visits are limited in time and may leave some issues unattended regarding all aspects of disease and overall health. This may adversely affect the decision making process and the prescribed treatment plan.
In order to understand the accurate clinical status of patients, particularly in the motor fluctuating stage of PD and to monitor results of intervention, the treating neurologist may need a more comprehensive picture of their patients' symptoms and lives during protracted periods and real life in their home environment.
The HBM apparatus used in this study will consist of a smartwatch (Apple watch) and a smartphone (Apple iPhone 8). The phone is pre-installed with an application which is part of the Intel® Pharma Analytics Platform. The mobile app was designed by usability experts and was tested with patients to ensure ease of use by an elderly population with PD.
The Intel platform is enhanced by a compendium of algorithms to extract clinical insights from the raw sensor data. Passive sensor data is transferred from the study smartwatch. The data includes three measures based on the smartwatch data: activity level, dyskinesia and tremor.
The study will be conducted at Movement Disorders Institute at Sheba Medical Center and will include two clinic visits and a 2-week HBM phase.
The first clinic visit as well as the 2-week home period will include the following daily assessments (once in "off" state and once in "on" state):
- 3- meter Timed up and go test (3mTUG)
- Finger tapping on smartphone (10 seconds, both hands)
- Hand tremor assessment: postural tremor (outstretched, 30 sec), rest tremor (30 sec)
- Pronation-supination
In addition, ePROs are captured with electronic home diaries. Participants will report the severity of PD symptoms they are experiencing on a 5-point scale throughout the day. For the duration of waking hours, participants will receive a notification on their phone to input information about their ON/OFF state every 30 minutes.
The primary objective is to correlate severity of fluctuating motor symptoms in PD patients using the Intel® Pharma Analytics Platform's derived passive sensor data (percentage of daily tremor time and percentage of daily dyskinesia time, percentage of daily "inactivity") in an exploratory manner with concomitant assessment of motor fluctuations and dyskinesia using the application's based electronic symptom diary and data of tremor, off time and dyskinesia using the MDS-UPDRS scale.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Home based monitoring, Sensor-based data, Motor fluctuations
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between sensor data and MDS-UPDRS data
To correlate severity of fluctuating motor symptoms in PD patients using Intel® Pharma Analytics Platform's derived passive sensor data (percentage of daily tremor time and percentage of daily dyskinesia time, percentage of daily "inactivity") in an exploratory manner with concomitant assessment of motor fluctuations and dyskinesia using the application's based electronic symptom diary and data of tremor, off time and dyskinesia using the MDS-UPDRS.
Measured: 2-3 weeks study period
Secondary outcomes (5)
Correlation between passive sensor data and PDQ-39 questionnaire
Correlate the results of passive sensor data regarding "level of activity" and "time of activity" with measures of Quality of life as captured by the PDQ-39
Measured: 2-3 weeks study period
Correlation between passive sensor data and electronic home diaries
Correlate the results passive sensor data of "level of activity" and "time of activity" with "on" and "off" data obtained from electronic home diary (on the same days).
Measured: 2-3 weeks study period
Correlation between motor test results (TUG, Static postural tests and finger tapping,) and relevant MDS-UPDRS items
Correlate the results of guided structured motor tests (TUG, Static postural tests and finger tapping,) during "off" and during "on" performed in the clinic (visit 1) and at home (twice in each condition) with the results of in-clinic MDS-UPDRS items: 3.1 walking, 3.11 freezing of gait, 3.12 postural stability, 3.4 finger taps during "off" and during "on"
Measured: 2-3 weeks study period
Assessing compliance of PD patients using wearable devices and adherence to assessment protocol.
The measures consist of: overall use of watch, Diary report -delay, Number of skipped daily questionnaires, number of skipped assessments, number of skipped medication reports, number of delayed medication reports, number of skipped medications intake, delay in medication intake and more.
Measured: 2-3 weeks study period
Correlation between medication regimen as prescribed by neurologist and patient adherence in real life
To correlate medication regimen as prescribed by neurologist and patient adherence in real life, using electronic medication intake reporting
Measured: 2-3 weeks study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start3 Nov 2019
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
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 Sheba 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- AbbVie, Intel Electronics Ltd.
- Responsible party
- Principal investigator, Dr. Sharon Hassin, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247294
- Sponsor's protocol ID
- 5428-18
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fluctuating Parkinson's Disease With Sensor-based Home Monitoring
- ClinicalTrials.gov ID
- NCT05247294
- Acronym / sponsor ID
- 5428-18
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Home based monitoring, Sensor-based data, Motor fluctuations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- AbbVie, Intel Electronics Ltd.
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 18 Feb 2022 (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 aim of this study is to implement home-based monitoring (HBM) using remote-capture wearable devices and patient reported outcomes (PROs) in a rather homogeneous subgroup of advanced Parkinson's Disease (PD) patients, suffering from significant motor fluctuations (MF) and Levodopa-induced dyskinesia (LID), over a two-week period.
The investigators aim to provide a more comprehensive picture of patient symptoms, severity, and fluctuations and compare these data to interview-derived clinical data.
Detailed description
Parkinson's Disease (PD) is a neuro-degenerative disorder affecting millions of people worldwide. PD is associated with both motor and non-motor symptoms that affect patients' functioning and Quality of life.
The motor symptoms consist of tremor, rigidity, bradykinesia and gait impairments. Additional important motor symptoms that are associated with chronic Levodopa therapy, are levodopa-induced dyskinesia and motor fluctuations.
Currently, the accepted clinical measurement of PD symptom severity is the Movement Disorders Society-unified Parkinson's disease rating scale (MDS-UPDRS), which is based, in part, on subjective and potentially recall-based reports by the patients and on semi-objective observations by the clinician.
On average, PD patients see their treating neurologist for in-clinic visits twice a year. These visits are limited in time and may leave some issues unattended regarding all aspects of disease and overall health. This may adversely affect the decision making process and the prescribed treatment plan.
In order to understand the accurate clinical status of patients, particularly in the motor fluctuating stage of PD and to monitor results of intervention, the treating neurologist may need a more comprehensive picture of their patients' symptoms and lives during protracted periods and real life in their home environment.
The HBM apparatus used in this study will consist of a smartwatch (Apple watch) and a smartphone (Apple iPhone 8). The phone is pre-installed with an application which is part of the Intel® Pharma Analytics Platform. The mobile app was designed by usability experts and was tested with patients to ensure ease of use by an elderly population with PD.
The Intel platform is enhanced by a compendium of algorithms to extract clinical insights from the raw sensor data. Passive sensor data is transferred from the study smartwatch. The data includes three measures based on the smartwatch data: activity level, dyskinesia and tremor.
The study will be conducted at Movement Disorders Institute at Sheba Medical Center and will include two clinic visits and a 2-week HBM phase.
The first clinic visit as well as the 2-week home period will include the following daily assessments (once in "off" state and once in "on" state):
- 3- meter Timed up and go test (3mTUG)
- Finger tapping on smartphone (10 seconds, both hands)
- Hand tremor assessment: postural tremor (outstretched, 30 sec), rest tremor (30 sec)
- Pronation-supination
In addition, ePROs are captured with electronic home diaries. Participants will report the severity of PD symptoms they are experiencing on a 5-point scale throughout the day. For the duration of waking hours, participants will receive a notification on their phone to input information about their ON/OFF state every 30 minutes.
The primary objective is to correlate severity of fluctuating motor symptoms in PD patients using the Intel® Pharma Analytics Platform's derived passive sensor data (percentage of daily tremor time and percentage of daily dyskinesia time, percentage of daily "inactivity") in an exploratory manner with concomitant assessment of motor fluctuations and dyskinesia using the application's based electronic symptom diary and data of tremor, off time and dyskinesia using the MDS-UPDRS scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced Parkinson's Disease (PD) patients, suffering from significant motor fluctuations (MF) and Levodopa-induced dyskinesia (LID)
Key inclusion criteria (7 listed)
- Diagnosis of idiopathic Parkinson's disease for at least 5 years
- Males or females over the age of 30
- Patients treated with oral levodopa (3 daily doses or more), reporting motor fluctuations and (preferably) with l-dopa-induced dyskinesia
- UPDRS-MDS 4.4 functional impact of fluctuations (mild + severe, 2-4)
- Hoehn \&Yahr stage 1-3 while ON
Key exclusion criteria (5 listed)
- Cognitive or psychiatric impairment that would preclude study participation as determined by the principal investigator
- Additional major comorbidities
- Levodopa-resistant tremor (tremor during ON)
- Levodopa-resistant freezing (freezing during ON)
- Previous surgical treatment for PD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between sensor data and MDS-UPDRS data
Time frame: 2-3 weeks study period
To correlate severity of fluctuating motor symptoms in PD patients using Intel® Pharma Analytics Platform's derived passive sensor data (percentage of daily tremor time and percentage of daily dyskinesia time, percentage of daily "inactivity") in an exploratory manner with concomitant assessment of motor fluctuations and dyskinesia using the application's based electronic symptom diary and data of tremor, off time and dyskinesia using the MDS-UPDRS.
5 secondary outcomes
Correlation between passive sensor data and PDQ-39 questionnaire
Time frame: 2-3 weeks study period
Correlation between passive sensor data and electronic home diaries
Time frame: 2-3 weeks study period
Correlation between motor test results (TUG, Static postural tests and finger tapping,) and relevant MDS-UPDRS items
Time frame: 2-3 weeks study period
Assessing compliance of PD patients using wearable devices and adherence to assessment protocol.
Time frame: 2-3 weeks study period
Correlation between medication regimen as prescribed by neurologist and patient adherence in real life
Time frame: 2-3 weeks study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Sheba Medical Center at 1 site in Israel.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 18 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 1 site in Israel. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between sensor data and MDS-UPDRS data (time frame: 2-3 weeks study period). 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 Feb 2022.