Deep Brain Stimulation Effects Study
The purpose of this study is to provide proof-of-concept that the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person. The study will also compare results of the test product to the commercially-available product.
Hypothesis: the test product will elicit successful test results in over 90% of test product.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Deep Brain Stimulation Effects: Human Proof-of-Concept Study|
- The HFR0001 device can elicit distinct intra-operative responses in subject symptoms. [ Time Frame: 9 months ] [ Designated as safety issue: No ]Responses include testing parameters and symptom effects
- Adverse events that occur with the acute implantation and intra-operative testing of the study device. [ Time Frame: 9 months. ] [ Designated as safety issue: Yes ]Characterization of all adverse events for all subjects from the beginning of the implant procedure through study discontinuation.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Experimental: Study device arm||
Device: Study device HFR0001
Study device will be tested for up to 2 hours prior to chronic device implant.
|Christian Albrechts University of Kiel|
|Kiel, Germany, D-24105|
|Principal Investigator:||H. Maximilian Mehdorn, MD, PhD||University Clinics Kiel, Department of Neurosurgery|