Optimizing DBS Electrode Placement and Programming

Withdrawn

• Conditions: Parkinson's Disease; Essential Tremor

• Registration Number: NCT01820390
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-14
• Study Start: 2013-03
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-20
• Primary Completion: 2015-07
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distance between Electrophysiology Results and Modeling Predictions (mm)	1 week	A comparison between electrophysiology results and modeling predictions will be made post-operatively.

Trial Locations

Locations (2)

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Department of Neurosurgery, University of Colorado; 🇺🇸 Aurora, Colorado, United States