Deep Brain Stimulation Effects Study
|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|
|Primary Completion Date :||November 2011|
|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.
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|