Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05247294 |
| Other study ID # |
5428-18 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2019 |
| Est. completion date |
February 24, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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):
1. 3- meter Timed up and go test (3mTUG)
2. Finger tapping on smartphone (10 seconds, both hands)
3. Hand tremor assessment: postural tremor (outstretched, 30 sec), rest tremor (30 sec)
4. 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.
