Humanitarian Device Exemption (Dystonia IRB)

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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

Tracking Information

First Submitted Date

December 13, 2007

First Posted Date

December 27, 2007

Last Update Posted Date

October 14, 2019

Descriptive Information

Brief Title

Humanitarian Device Exemption

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.

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 Type

Expanded Access

Intervention

Device: Medtronic Activa Gpi

Activa Therapy, Gpi

Other Names:

DBS
Gpi
Activa Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Expanded Access Status

Approved for marketing

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT00580658

Current Responsible Party

Peter Konrad, Vanderbilt University

Original Responsible Party

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

Current Study Sponsor

Vanderbilt University Medical Center

Original Study Sponsor

Vanderbilt University

Collaborators

Not Provided

Investigators

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

PRS Account

Vanderbilt University Medical Center

Verification Date

October 2019

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