Parkinson Disease
Conditions
Keywords
deep brain stimulation, advanced Parkinson's disease, DBS, dDBS
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.
Interventions
None listed
Sponsors
Hospital District of Helsinki and Uusimaa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Finland
Outcome results
None listed