Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease

Study Overview
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Brief Summary
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The aim of the study is to assess the clinical outcome in patients with Parkinson's disease treated with directional deep brain stimulation (dDBS). The patients have been selected for the dDBS treatment by their treating neurologist. The study is a registry-based follow-up study.

Detailed Description
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The study group consists of patients with advanced Parkinson's disease treated with directional deep brain stimulation in Helsinki University Hospital between 2017 - 2020. The study is a registry-based follow-up study. The aim of the study is to assess the clinical outcome and possible adverse effects of the dDBS treatment. The data will be collected from the patient records. The observed time points are 6-month's, 12-month's and 18-month's postoperative visits. The following data will collected: the scores of Unified Parkinson's disease questionnaire part III (UPDRS-III), Non-Motor Symptoms Questionnaire (NMS-quest), Beck Depression Inventory (BDI), Mini-Mental State Examination (MMSE), Abnormal Involuntary Movement Scale (AIMS) evaluated in the screening phase for dDBS treatment and at 6-months' follow-up. Possible levodopa equivalent dose changes, LEDDs, will also be assessed at these time points.

Official Title
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Directional Deep Brain Stimulation in Advanced Parkinson's Disease - Clinical Review

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced Parkinson's disease and treated with directional deep brain stimulation Exclusion Criteria: patients with advanced Parkinson's disease and not treated with directional deeb brain stimulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The actual use of directional DBS stimulation in everyday life during the follow-up | The use of directionality in DBS in patients with PD in everyday life | 6-18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of UPDRS part III score during the DBS treatment | The changes of UPDRS part III score during the DBS treatment | From the initiation of DBS treatment to 18-month's postoperative visit | 
| Evaluation of the dDBS parameters | The use of dDBS, active contacts and the dDBS programming protocol will be studied. | 6 months to 18 months | 
| Possible adverse effects | Possible adverse effects of dDBS operation and treatment will be collected | 6 months-18 months | 
| LEDDs | Possible changes of levodopa equivalent doses, LEDDs, are studied | From preoperative visit to 18 month's postoperative visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep brain stimulation, advanced Parkinson's disease, DBS, dDBS