Status:

COMPLETED

Assessment of Fluctuating Parkinson's Disease With Sensor-based Home Monitoring

Lead Sponsor:

Sheba Medical Center

Collaborating Sponsors:

AbbVie

Intel Electronics Ltd.

Conditions:

Parkinson Disease

Eligibility:

All Genders

30+ years

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 Di...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

November 3 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 24 2021

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT05247294

Start Date

November 3 2019

End Date

February 24 2021

Last Update

February 18 2022

Active Locations (1)

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Movement Disorders Institution, Sheba Medical Center

Ramat Gan, Israel