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

NCT04287465•Hospital District of Helsinki and Uusimaa

Summary

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.

Eligibility

Age

0 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Advanced Parkinson's disease
•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

•a major depression
•on-going psychosis
•a significant brain atrophy observed in a brain MRI
•a suspicion of atypical parkinsonism
•marked cognitive decline.

Locations (1)

HUH Meilahti Hospital, department of neurology

Helsinki, Finland

Key Dates

Start Date

August 1, 2018

Primary Completion Date

December 1, 2024

Completion Date

December 31, 2025

Last Updated

September 28, 2023

Enrollment

ESTIMATED participants

Conditions

Parkinson DiseaseDeep Brain Stimulation

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients