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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

Study Description
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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.

Condition or disease Intervention/treatment
Dystonia Device: Medtronic Activa Gpi

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 Design
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Study Type : Expanded Access
Official Title: Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Interventions
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Intervention Details:
  • Device: Medtronic Activa Gpi
    Activa Therapy, Gpi
    Other Names:
    • DBS
    • Gpi
    • Activa Therapy
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580658


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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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
More Information
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Responsible Party: Peter Konrad, Professor, Director of Functional Neurosurgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00580658    
Other Study ID Numbers: 060155
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Keywords provided by Peter Konrad, Vanderbilt University:
Dystonia
DBS
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases