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

Active, not recruiting

• Conditions: Parkinson Disease; Deep Brain Stimulation

• Registration Number: NCT04287465
• Lead Sponsor: Hospital District of Helsinki and Uusimaa

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

HUH Meilahti Hospital, department of neurology; 🇫🇮 Helsinki, Finland