Deep Brain Stimulation Effects Study

NCT ID: NCT01098565

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-11-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

Study device arm

Group Type: EXPERIMENTAL

Study device HFR0001

Intervention Type: DEVICE

Study device will be tested for up to 2 hours prior to chronic device implant.

Interventions

Study device HFR0001

Study device will be tested for up to 2 hours prior to chronic device implant.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedtronicNeuro

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H. Maximilian Mehdorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinics Kiel, Department of Neurosurgery

Locations

Christian Albrechts University of Kiel

Kiel, , Germany

Countries

Germany

Other Identifiers

1654

Identifier Type: -

Identifier Source: org_study_id