Deep Brain Stimulation Effects Study

Deep Brain Stimulation Effects: Human Proof-of-Concept Study

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Study device HFR0001

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, D-24105
    • Christian Albrechts University of Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The HFR0001 device can elicit distinct intra-operative responses in subject symptoms.	Responses include testing parameters and symptom effects	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events that occur with the acute implantation and intra-operative testing of the study device.	Characterization of all adverse events for all subjects from the beginning of the implant procedure through study discontinuation.	9 months.

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Principal Investigator: H. Maximilian Mehdorn, MD, PhD, University Clinics Kiel, Department of Neurosurgery

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: April 1, 2010
• First Posted (ESTIMATE): April 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 1654