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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Hospital District of Helsinki and Uusimaa
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Updated on 19 February 2024
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brain stimulation
parkinson's disease
tremor
levodopa
dyskinesia
general anesthesia

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.

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.

Details
Condition Deep Brain Stimulation, Parkinson's Disease, Parkinson's Disease
Age 80years or below
Clinical Study IdentifierNCT04287465
SponsorHospital District of Helsinki and Uusimaa
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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