Trials / Unknown
UnknownNCT04287465
Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Hospital District of Helsinki and Uusimaa · Academic / Other
- Sex
- All
- Age
- 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2024-12-01
- Completion
- 2025-12-31
- First posted
- 2020-02-27
- Last updated
- 2023-09-28
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT04287465. Inclusion in this directory is not an endorsement.