Deep Brain Stimulation Effects Study
This study is ongoing, but not recruiting participants.
Sponsor:
MedtronicNeuro
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01098565
First received: March 25, 2010
Last updated: June 15, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (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: | June 15, 2012 |
| 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 May 19, 2013