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Humanitarian Device Exemption (Dystonia IRB)

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00580658
First received: December 13, 2007
Last updated: May 11, 2016
Last verified: May 2016
History of Changes
  Purpose
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.

Condition Intervention
Dystonia
 Device: Medtronic Activa Gpi

Study Type: Expanded Access     What is Expanded Access?
Official Title: Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy

Resource links provided by NLM:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Further study details as provided by Vanderbilt University:
Study Start Date: May 2006
Estimated Study Completion Date: May 2020
Intervention Details:
    Device: Medtronic Activa Gpi
    Activa Therapy, Gpi
    Other Names:
    • DBS
    • Gpi
    • Activa 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.
  Eligibility
Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580658

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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
  More Information

Responsible Party: Peter Konrad, Professor, Director of Functional Neurosurgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00580658     History of Changes
Other Study ID Numbers: 060155 
Study First Received: December 13, 2007
Last Updated: May 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 29, 2016