Skip to main content
OpenTrials
Completed

NCT Number: NCT02701803

Parkinson's KinetiGraph, PKG in Patients With Deep Brain Stimulation and Continuous Levodopa Infusion Therapy

In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device. In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing it with written patient diaries.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HUH Meilahti Hospital, department of neurology

Helsinki, 00029, Finland

About this study

In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ logger (PKG) device which is a movement and acceleration measuring device.

A measurement is done before and after the implantation of selected therapy. PKG will measure automatically in every two minutes the movement of selected limb (usually the more affected upper extremity) for six days. At the same time a patient will keep a written diary of his/her Parkinsonian symptoms. Diary and collected PKG data will be compared. PKG will also remind with vibration the patient of the time drug administration and the patient can confirm this with pressing a button on PKG. The collected data will be transmitted to a computer and analyzed mathematically to produce a visual graph of daily movements. The aim is to evaluate PKG's usability in measuring Parkinsonian symptoms and in evaluation the outcome of DBS and levodopa therapy. Main parameters in evaluation are bradykinesia score and dyskinesia score.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with diagnosed Parkinson's disease
  • Parkinson's disease is in advanced state (defined by the treating physician)
  • A good response with over 30 % improvement of scores in Unified Parkinson's disease rating scale part III in pre-DBS evaluation

Exclusion criteria

  • Age older than 70 years (this is a clinical exclusion criteria for DBS treatment)
  • No history of psychosis or depression (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)
  • No diagnosed dementia (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)

Treatment and study plan

Parkinson's KinetiGraph™ logger

Device

Logger is recording device which records the movement and acceleration of upper extremity

Primary outcomes

  1. Bradykinesia score

    Time frame: 6 months

    BKS is summary of bradykinesia presented in PKG recordings, BKS, 0 - 50

Secondary outcomes

  1. Dyskinesia score

    Time frame: 6 months

    DKS summary of dyskinesia presented in PKG recordings, DKS, 0 - 50

Sponsors and collaborators

Lead sponsor

Hospital District of Helsinki and Uusimaa

Other

Registry information

Official study title

Ambulatory Movement Registration in Patients With Deep Brain Stimulation and Continuous Intraduodenal Levodopa Therapy

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 8, 2016
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.