We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Optimizing DBS Electrode Placement and Programming

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01820390
Recruitment Status : Withdrawn (Funding discontinued.)
First Posted : March 28, 2013
Last Update Posted : February 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Deep brain stimulation (DBS) has become the primary surgical therapy for the treatment of motor symptoms associated with Parkinson's disease (PD), and for essential tremor (ET). Although an effective and relatively safe procedure with expanding indications, opportunities exist for the optimization of the current procedure.

The investigators therefore propose, in a group of patients undergoing DBS surgery for the treatment of PD or ET, to use a combination of high‐field imaging modalities, intraoperative electrophysiology, external sensor interfaces, and computational modeling, to gather information on the utility of using these techniques to optimize DBS electrode placement and programming.


Condition or disease
Parkinson's Disease Essential Tremor

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimizing DBS Electrode Placement and Programming Using a Combination of High‐Field MRI, Intraoperative Electrophysiology, and Computational Modeling.
Study Start Date : March 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Distance between Electrophysiology Results and Modeling Predictions (mm) [ Time Frame: 1 week ]
    A comparison between electrophysiology results and modeling predictions will be made post-operatively.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the population of patients undergoing DBS surgery at the University of Minnesota Medical Center, for the treatment of (1) Parkinson's disease, or (2) essential tremor.
Criteria

Inclusion Criteria:

  • A diagnosis of idiopathic Parkinson's disease or essential tremor
  • Ability to provide informed consent

Exclusion Criteria:

  • Claustrophobia or other conditions that prevent undergoing MR imaging
  • MMSE score < 23
  • Significant neurological diagnosis other than PD or ET.
  • Idiopathic dystonia
Contacts and Locations

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): NCT01820390


Locations
United States, Colorado
Department of Neurosurgery, University of Colorado
Aurora, Colorado, United States, 80045
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Medtronic
Investigators
Principal Investigator: Aviva D Abosch, M.D., Ph.D. University of Colorado, Denver
More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01820390     History of Changes
Other Study ID Numbers: 13-1837
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by University of Colorado, Denver:
Deep Brain Stimulation (DBS)
Parkinson's Disease
Essential Tremor

Additional relevant MeSH terms:
Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms