Clinical trial NCT00580658: Humanitarian Device Exemption
Official title: Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Dystonia
Keywords: Dystonia
DBS
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-12-27
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University, Dept. Neurosurgery
name: Peter E Konrad, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University, Dept. Neurosurgery
name: Dario Englot, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University, Dept. Neurology
name: Thomas L Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University, Dept. Neurology
name: John Y Fang, MD
role: PRINCIPAL_INVESTIGATOR
References: