Deep Brain Stimulation, Parkinson Disease
Conditions
Brief summary
To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.
Detailed description
To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia. In awake group, 10 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation and testing were performed while the patients were awake. In asleep group, 14 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation were performed while the patients were under general anesthesia. The clinical outcome of the DBS treatment, possible adverse effects and the electrode placement will be compared within these two groups.
Interventions
None listed
Sponsors
University of Turku
Hospital District of Helsinki and Uusimaa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
Advanced Parkinson's disease * The clinical decision of DBS treatment * The clinical inclusion criteria of DBS treatment: * drug-resistant tremor * severe daily motor fluctuations or dyskinesia in despite of the optimal oral medication * an improvement of UPDRS III scores over 30 % in levodopa challenge test.
Exclusion criteria
* The general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of UPDRS III score | 6 months | The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of levodopa equivalent dose, LED | 6 months | The change of levodopa equivalent dose (LED 0 - 2000 mg) at 6-months' follow-up compared to preoperative LED |
| Electrode trajectory | 6 months | The comparison of the actual trajectory of the DBS electrode and the anticipated trajectory of the DBS electrode in both patient groups |
Countries
Finland
Outcome results
None listed