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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Parkinson's KinetiGraph™ logger


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Parkinson's KinetiGraph™ logger|Logger is recording device which records the movement and acceleration of upper extremity|

What is the study measuring?
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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 |