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

Hospital District of Helsinki and Uusimaa

Status: Active, not recruiting

Conditions: Parkinson Disease; Deep Brain Stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT04287465

HospitalHDU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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.