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Humanitarian Device Exemption (Dystonia IRB)

This treatment has been approved for sale to the public.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00580658
First received: December 13, 2007
Last updated: January 11, 2010
Last verified: January 2010

December 13, 2007
January 11, 2010
May 2006
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Complete list of historical versions of study NCT00580658 on ClinicalTrials.gov Archive Site
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Humanitarian Device Exemption
Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy

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
Not Provided
Not Provided
Dystonia
Device: Medtronic Activa Gpi
Activa Therapy, Gpi
Other Names:
  • DBS
  • Gpi
  • Activa Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
Not Provided
May 2020
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Inclusion Criteria:

  • Patients whose ages are in the range of 7 and 99 years old
  • Patients who are diagnosed with chronic, intractable (drug refractory)primary dystonia, including generalized and or segmental dystonia, hemidystonia, and cervical dystonia (torticollis)as determined by a neurologist or neurosurgeon.
  • Patients who have failed appropriate medical therapy as determined by the SMD conference

Exclusion Criteria:

  • Patients younger than 7 years old
  • Patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist.
  • Patients who have not had an adequate trial of medical or non-surgical therapy as determined by the SMD conference.
  • Patients not deemed good candidates by the SMD conference group.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580658
060155
Yes
Peter E. Konrad, MD, Ph.D., Vanderbilt University, Dept. Neurosurgery
Vanderbilt University
Not Provided
Principal Investigator: Peter E Konrad, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
Principal Investigator: Joseph S Neimat, MD, MS 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
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP