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Humanitarian Device Exemption (Dystonia IRB)

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.
 
ClinicalTrials.gov Identifier: NCT00580658
Expanded Access Status : Approved for marketing
First Posted : December 27, 2007
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University

Tracking Information
First Submitted Date December 13, 2007
First Posted Date December 27, 2007
Last Update Posted Date October 14, 2019
 
Descriptive Information
Brief Title Humanitarian Device Exemption
Brief Summary The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.
Detailed Description The purpose of this IRB approved study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.
Study Type Expanded Access
Intervention Device: Medtronic Activa Gpi
Activa Therapy, Gpi
Other Names:
  • DBS
  • Gpi
  • Activa Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00580658
Current Responsible Party Peter Konrad, Vanderbilt University
Original Responsible Party Peter E. Konrad, MD, Ph.D., Vanderbilt University, Dept. Neurosurgery
Current Study Sponsor Vanderbilt University Medical Center
Original Study Sponsor Vanderbilt University
Collaborators Not Provided
Investigators
Principal Investigator: Peter E Konrad, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Dario Englot, MD PhD Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Thomas L Davis, MD Vanderbilt University, Dept. Neurology
Principal Investigator: John Y Fang, MD Vanderbilt University, Dept. Neurology
PRS Account Vanderbilt University Medical Center
Verification Date October 2019