Directional Deep Brain Stimulation in Advanced Parkinson's Disease - Clinical Review
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Hospital District of Helsinki and Uusimaa
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The actual use of directional DBS stimulation in everyday life during the follow-up
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Maija Koivu
M.D., Specialist in Neurology
Hospital District of Helsinki and Uusimaa
Eligibility 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
Outcomes
Primary Outcomes
The actual use of directional DBS stimulation in everyday life during the follow-up
Time Frame: 6-18 months
The use of directionality in DBS in patients with PD in everyday life
Secondary Outcomes
- Evaluation of the dDBS parameters(6 months to 18 months)
- The changes of UPDRS part III score during the DBS treatment(From the initiation of DBS treatment to 18-month's postoperative visit)
- Possible adverse effects(6 months-18 months)
- LEDDs(From preoperative visit to 18 month's postoperative visit)