Status:
UNKNOWN
Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
Lead Sponsor:
Hospital District of Helsinki and Uusimaa
Collaborating Sponsors:
University of Turku
Conditions:
Parkinson Disease
Deep Brain Stimulation
Eligibility:
All Genders
Up to 80 years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04287465
Start Date
August 1 2018
End Date
December 31 2025
Last Update
September 28 2023
Active Locations (1)
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1
HUH Meilahti Hospital, department of neurology
Helsinki, Finland, 00029