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

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ClinicalTrials.gov Identifier: NCT01210781
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2010
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment
Movement Disorders Epilepsy Procedure: deep brain stimulation (DBS)

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 Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation
Study Start Date : September 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. neurological outcome [ Time Frame: 5 years ]
    UPDRS


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01210781     History of Changes
Other Study ID Numbers: DBS
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016

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

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