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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01210781
First received: September 27, 2010
Last updated: May 27, 2016
Last verified: May 2016
  Purpose

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

Condition Intervention
Movement Disorders
Epilepsy
Procedure: deep brain stimulation (DBS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • neurological outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    UPDRS


Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: deep brain stimulation (DBS)
    deep brain stimulation (DBS) is in itself not part of this study but a clinical indication. The study aims at documenting DBS parameters and outcome
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients implanted with DBS electrodes at our institution
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210781

Locations
Switzerland
University Hospital Zurich, Neurosurgery
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Johannes Sarnthein, MD University Hospital Zurich, Division of Neurosurgery
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01210781     History of Changes
Other Study ID Numbers: DBS 
Study First Received: September 27, 2010
Last Updated: May 27, 2016
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
All indication for deep brain stimulation (DBS)

Additional relevant MeSH terms:
Epilepsy
Movement Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2016