Humanitarian Device Exemption - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00580658

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

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dystonia

U.S. FDA Resources

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

Further study details as provided by Vanderbilt University:

Study Start Date:	May 2006
Estimated Study Completion Date:	May 2020

Intervention Details:

Activa Therapy, 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.

Eligibility

Ages Eligible for Study:	7 Years and older
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

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:	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

More Information

Responsible Party:	Vanderbilt University, Dept. Neurosurgery ( Peter E. Konrad, MD, Ph.D. )
Study ID Numbers:	060155
Study First Received:	December 13, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00580658
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Dystonia

Study placed in the following topic categories:

Dystonic Disorders
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

Neurologic Manifestations
Dystonia
Dyskinesias

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009