dDBS: Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- The actual use of directional DBS stimulation in everyday life during the follow-up [6-18 months]
The use of directionality in DBS in patients with PD in everyday life
Secondary Outcome Measures
- The changes of UPDRS part III score during the DBS treatment [From the initiation of DBS treatment to 18-month's postoperative visit]
The changes of UPDRS part III score during the DBS treatment
- Evaluation of the dDBS parameters [6 months to 18 months]
The use of dDBS, active contacts and the dDBS programming protocol will be studied.
- Possible adverse effects [6 months-18 months]
Possible adverse effects of dDBS operation and treatment will be collected
- LEDDs [From preoperative visit to 18 month's postoperative visit]
Possible changes of levodopa equivalent doses, LEDDs, are studied
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HUH Meilahti Hospital, department of neurology | Helsinki | Finland | 00029 |
Sponsors and Collaborators
- Maija Koivu
Investigators
- Principal Investigator: Eero Pekkonen, MD, PhD, Helsinki University Central Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schäfer H, Bötzel K, Daniels C, Deutschländer A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. Erratum in: N Engl J Med. 2006 Sep 21;355(12):1289.
- Weaver FM, Follett K, Stern M, Hur K, Harris C, Marks WJ Jr, Rothlind J, Sagher O, Reda D, Moy CS, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein J, Stoner G, Heemskerk J, Huang GD; CSP 468 Study Group. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009 Jan 7;301(1):63-73. doi: 10.1001/jama.2008.929.
- HospitalIDHU