Deep Brain Stimulation Effects Study
This study has been terminated.
(The goal of collecting proof-of-concept information was met through additional modeling studies, new published evidence and information collected from the study)
Information provided by (Responsible Party):
First received: March 25, 2010
Last updated: August 1, 2013
Last verified: August 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.
Device: Study device HFR0001
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
||Deep Brain Stimulation Effects: Human Proof-of-Concept Study
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject is indicated for Activa® DBS implant for the treatment of Parkinson's disease and scheduled for surgery at the study site.
- Subject is willing to sign the informed consent to participate in the study.
- Subject is 18 years of age or older.
- Subject is a male or non-pregnant female.
- Subject has no factors that would put the subject at an additional risk for intra-operative or postoperative bleeding. This includes underlying disorders of the coagulation cascade (eg, hemophilia), disorders that affect platelet count or function (eg, Von Willebrand's disease), as well as administration of any anti-platelet or anti-coagulant medication in the 7 days prior to surgery, or any history of anticoagulant or aspirin use, that in the view of the neurosurgeon or neurologist would place the subject at an increased risk for intra-operative or postoperative bleeding.
- Subject is indicated for DBS for treating a disorder other than Parkinson's disease.
- Subject has any medical contraindications to undergoing DBS surgery, (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery).
- Subject has a history of hemorrhagic stroke.
- Subject has a history of a neurosurgical ablation procedure.
- Subject is currently enrolled in or plans to enroll in any concurrent study that may confound the results of this study, as determined by the investigator or Medtronic.
- Subject has a diagnosis of acute myocardial infarction or cardiac arrest less than or equal to 6 months prior to the screening testing.
- Subject has a history of a seizure disorder
- Subject requires short surgery time due to general health issues, as determined by the investigator.
- Subject is a woman who is pregnant or planning to become pregnant, or a woman of child-bearing potential, who is not using a medically-acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to the investigational procedure visit.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098565
|Christian Albrechts University of Kiel
|Kiel, Germany, D-24105 |
||H. Maximilian Mehdorn, MD, PhD
||University Clinics Kiel, Department of Neurosurgery
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 25, 2010
||August 1, 2013
||Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 30, 2016
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases