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Humanitarian Device Exemption (Dystonia IRB)

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580658
First Posted: December 27, 2007
Last Update Posted: May 13, 2016
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.
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University
December 13, 2007
December 27, 2007
May 13, 2016
 
Humanitarian Device Exemption
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.
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.
Expanded Access
Device: Medtronic Activa Gpi
Activa Therapy, Gpi
Other Names:
  • DBS
  • Gpi
  • Activa Therapy
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00580658
Peter Konrad, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Peter E Konrad, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Hong Yu, MD Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Thomas L Davis, MD Vanderbilt University, Dept. Neurology
Principal Investigator: John Y Fang, MD Vanderbilt University, Dept. Neurology
Vanderbilt University
May 2016
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