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

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Parkinson's KinetiGraph™ logger

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • HUH Meilahti Hospital, department of neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population is consisted of patients with advanced Parkinson's disease in HUH neurological clinic. The treatment decision of deep brain stimulation and/or continuous intraduodenal levodopa therapy is done clinically by the treating physician. The patients are enrolled in the study after the clinical decision is made.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bradykinesia score	BKS is summary of bradykinesia presented in PKG recordings, BKS, 0 - 50	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyskinesia score	DKS summary of dyskinesia presented in PKG recordings, DKS, 0 - 50	6 months

Collaborators and Investigators

• Sponsor: Hospital District of Helsinki and Uusimaa
• Investigators: Study Director: Eero Pekkonen, M.D., Ph.D., HUH, Meilahti Hospital, department of neurology

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HospitalDHU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No