Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Helsinki, Finland, 00029
- HUH Meilahti Hospital, department of neurology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change of UPDRS III score
Time Frame: 6 months
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The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of levodopa equivalent dose, LED
Time Frame: 6 months
|
The change of levodopa equivalent dose (LED 0 - 2000 mg) at 6-months' follow-up compared to preoperative LED
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6 months
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Electrode trajectory
Time Frame: 6 months
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The comparison of the actual trajectory of the DBS electrode and the anticipated trajectory of the DBS electrode in both patient groups
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6 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Eero Pekkonen, M.D-, Ph.D., HUH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HospitalHDU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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