Optimizing DBS Electrode Placement and Programming

This study has been withdrawn prior to enrollment.
(Funding discontinued.)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01820390
First received: January 14, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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
Parkinson's Disease
Essential Tremor

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Distance between Electrophysiology Results and Modeling Predictions (mm) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    A comparison between electrophysiology results and modeling predictions will be made post-operatively.


Enrollment: 0
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 14, 2013
Last Updated: February 18, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014