Deep Brain Stimulation Effects Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):

Brief Summary:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study device arm Device: Study device HFR0001
Study device will be tested for up to 2 hours prior to chronic device implant.

Primary Outcome Measures :
  1. The HFR0001 device can elicit distinct intra-operative responses in subject symptoms. [ Time Frame: 9 months ]
    Responses include testing parameters and symptom effects

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01098565

Christian Albrechts University of Kiel
Kiel, Germany, D-24105
Sponsors and Collaborators
Principal Investigator: H. Maximilian Mehdorn, MD, PhD University Clinics Kiel, Department of Neurosurgery

Responsible Party: MedtronicNeuro Identifier: NCT01098565     History of Changes
Other Study ID Numbers: 1654
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases