Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode

Hospital District of Helsinki and Uusimaa30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Parkinson Disease Deep Brain Stimulation

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

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 exclusion criteria for DBS treatment: * a major depression * on-going psychosis * a significant brain atrophy observed in a brain MRI * a suspicion of atypical parkinsonism * marked cognitive decline.

Locations (1)

HUH Meilahti Hospital, department of neurology

Helsinki, Finland

Outcomes

Primary Outcomes

The change of UPDRS III score

The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score

Time frame: 6 months

Secondary Outcomes

The change of levodopa equivalent dose, LED

The change of levodopa equivalent dose (LED 0 - 2000 mg) at 6-months' follow-up compared to preoperative LED

Time frame: 6 months

Electrode trajectory

The comparison of the actual trajectory of the DBS electrode and the anticipated trajectory of the DBS electrode in both patient groups

Time frame: 6 months

Data from ClinicalTrials.gov

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