Feasibility Study to Evaluate Deep Brain Stimulation (DBS) Settings for the Treatment of Parkinson's Disease
NCT01230151 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2011-02-18
Summary
The purpose of this study is to assess the cognitive performance in patients with advanced Parkinson's disease receiving Deep Brain Stimulation (DBS) with settings predetermined clinically to settings derived from a patient-specific computational model.
Conditions
Interventions
- DEVICE
-
GUIDE software, Version 0.1
The GUIDE software uses computer-based models to determine the spread of stimulation from DBS therapy into surrounding nuclei of the brain. The software models stimulation and is not used to program or communicate with the patient's implanted DBS System. The software was recently validated in a multi-center clinical study.
- DEVICE
-
Clinically defined stimulation parameters
Stimulation parameters clinically determined prior to start of clinical study
Sponsors & Collaborators
-
Intelect Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2011-12-31
Countries
- United States
Study Locations
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