Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation

November 30, 2023 updated by: University of Zurich

Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement.

The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

  • Trial with surgical intervention

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement.

The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

Study Type

Observational

Enrollment (Estimated)

500

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

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Neurosurgery

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

consecutive patients implanted with DBS electrodes at our institution

Description

Inclusion criteria:

  • Patients fullfill all criteria for implantation of deep brain stimulation (DBS) electrodes
  • Patients are able to give informed written consent

Exclusion criteria:

  • Patients do not their give informed written consent

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
neurological outcome
Time Frame: 5 years
UPDRS
5 years

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Johannes Sarnthein, Prof Dr, University Hospital Zurich, Division of Neurosurgery

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

September 1, 2009

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimated)

September 28, 2010

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBS

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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