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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT02701803
• Lead Sponsor: Hospital District of Helsinki and Uusimaa

Brief Summary

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Primary Completion: 2017-12
• Study Completion: 2018-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bradykinesia score	6 months	BKS is summary of bradykinesia presented in PKG recordings, BKS, 0 - 50

Secondary Outcome Measures

Name	Time	Method
Dyskinesia score	6 months	DKS summary of dyskinesia presented in PKG recordings, DKS, 0 - 50

Trial Locations

Locations (1)

HUH Meilahti Hospital, department of neurology; 🇫🇮 Helsinki, Finland