Deep Brain Stimulation Effects Study
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|ClinicalTrials.gov Identifier: NCT01098565|
Recruitment Status : Terminated (The goal of collecting proof-of-concept information was met through additional modeling studies, new published evidence and information collected from the study)
First Posted : April 2, 2010
Last Update Posted : August 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Study device HFR0001||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Deep Brain Stimulation Effects: Human Proof-of-Concept Study|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
|Experimental: Study device arm||
Device: Study device HFR0001
Study device will be tested for up to 2 hours prior to chronic device implant.
- The HFR0001 device can elicit distinct intra-operative responses in subject symptoms. [ Time Frame: 9 months ]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. ]Characterization of all adverse events for all subjects from the beginning of the implant procedure through study discontinuation.
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): NCT01098565
|Christian Albrechts University of Kiel|
|Kiel, Germany, D-24105|
|Principal Investigator:||H. Maximilian Mehdorn, MD, PhD||University Clinics Kiel, Department of Neurosurgery|