NCT05247294

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

January 26, 2022

Last Update Submit

February 15, 2022

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseHome based monitoringSensor-based dataMotor fluctuations

Outcome Measures

Primary Outcomes (1)

  • 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.

    2-3 weeks study period

Secondary Outcomes (5)

  • Correlation between passive sensor data and PDQ-39 questionnaire

    2-3 weeks study period

  • Correlation between passive sensor data and electronic home diaries

    2-3 weeks study period

  • Correlation between motor test results (TUG, Static postural tests and finger tapping,) and relevant MDS-UPDRS items

    2-3 weeks study period

  • Assessing compliance of PD patients using wearable devices and adherence to assessment protocol.

    2-3 weeks study period

  • Correlation between medication regimen as prescribed by neurologist and patient adherence in real life

    2-3 weeks study period

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Advanced Parkinson's Disease (PD) patients, suffering from significant motor fluctuations (MF) and Levodopa-induced dyskinesia (LID)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Movement Disorders Institution, Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Sharon Hassin

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 18, 2022

Study Start

November 3, 2019

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

IL(1)