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| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
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The purpose of this study is to identify factors predicting good results in patients treated with deep brain stimulation for Parkinson's disease. The study includes a comparison of two surgical methods used to provide this therapy.
The study will prospectively examine the effects of deep brain stimulation of the subthalamic nucleus (STN-DBS) on motor function, quality of life and cognitive function in Parkinson's disease (PD) patients treated at Rikshospitalet University Hospital. The aim is to identify which factors that predict good treatment outcome, in order to improve patient selection of this generally highly effective, but specialized and expensive treatment.
The study has several aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single microelectrode | Active Comparator | Surgical procedure performed using single microelectrode recording guidance intraoperatively |
|
| Multiple microelectrode | Active Comparator | Surgical procedure performed using multiple microelectrode recording guidance intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation of the subthalamic nucleus | Procedure | Chronic bilateral deep brain stimulation in the nucleus subthalamicus is performed using the most effective of four electrode contacts identified during testing of stimulation settings. Stimulation settings will be variable and adjusted according to the symptoms of each individual patient. Stimulation parameters will be recorded at each individual examination. Dopaminergic and other necessary medication will be given according to the need of each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the motor score of the New-UPDRS (part III) OFF medication | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Clinical Dyskinesia Rating Scale score | 12 months | |
| Change from baseline in ADL function (UPDRS part II) | 12 months | |
| Change from baseline in Mattis Dementia Rating Scale score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Espen Dietrichs, MD, PhD | Department of Neurology, Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0027 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30009214 | Derived | Bjerknes S, Toft M, Konglund AE, Pham U, Waage TR, Pedersen L, Skjelland M, Haraldsen I, Andersson S, Dietrichs E, Skogseid IM. Multiple Microelectrode Recordings in STN-DBS Surgery for Parkinson's Disease: A Randomized Study. Mov Disord Clin Pract. 2018 May 8;5(3):296-305. doi: 10.1002/mdc3.12621. eCollection 2018 May-Jun. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 12 months |
| Change in social functioning (Social adjustment scale-SR) | 12 months |
| Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life) | 12 months |
| Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index) | 12 months |
| Frequency of new or worsened psychiatric symptoms | 12 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |