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)
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01098565
First received: March 25, 2010
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Parkinson's Disease
Device: Study device HFR0001
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 6
Study Start Date: April 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study device arm Device: Study device HFR0001
Study device will be tested for up to 2 hours prior to chronic device implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098565

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

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01098565     History of Changes
Other Study ID Numbers: 1654
Study First Received: March 25, 2010
Last Updated: August 1, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 17, 2014