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

September 26, 2023 updated by: Maija Koivu, Hospital District of Helsinki and Uusimaa
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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • HUH Meilahti Hospital, department of neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced Parkinson's disease and their willingness to undergo DBS operation and treatment.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of UPDRS III score
Time Frame: 6 months
The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score
6 months

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
6 months
Electrode trajectory
Time Frame: 6 months
The comparison of the actual trajectory of the DBS electrode and the anticipated trajectory of the DBS electrode in both patient groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital District of Helsinki and Uusimaa

Collaborators

University of Turku

Investigators

  • Study Director: Eero Pekkonen, M.D-, Ph.D., HUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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