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Humanitarian Device Exemption

NCT00580658 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2019-10-14

No results posted yet for this study

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.

Conditions

  • Dystonia

Interventions

DEVICE

Medtronic Activa Gpi

Activa Therapy, Gpi

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Peter E Konrad, MD, Ph.D. · Vanderbilt University, Dept. Neurosurgery

  • Dario Englot, MD PhD · Vanderbilt University, Dept. Neurosurgery

  • Thomas L Davis, MD · Vanderbilt University, Dept. Neurology

  • John Y Fang, MD · Vanderbilt University, Dept. Neurology

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00580658 on ClinicalTrials.gov