Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
NCT ID: NCT04287465
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
30 participants
OBSERVATIONAL
2018-08-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* The clinical decision 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
* on-going psychosis
* a significant brain atrophy observed in a brain MRI
* a suspicion of atypical parkinsonism
* marked cognitive decline.
80 Years
ALL
No
Sponsors
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University of Turku
OTHER
Hospital District of Helsinki and Uusimaa
OTHER
Responsible Party
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Maija Koivu
Principal Investigator
Principal Investigators
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Eero Pekkonen, M.D-, Ph.D.
Role: STUDY_DIRECTOR
HUH
Locations
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HUH Meilahti Hospital, department of neurology
Helsinki, , Finland
Countries
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Other Identifiers
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HospitalHDU
Identifier Type: -
Identifier Source: org_study_id
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