Humanitarian Device Exemption

NCT00580658 | Unknown

• 1 other identifier: 060155
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Keywords

Dystonia; DBS

Interventions

Medtronic Activa Gpi DEVICE

Activa Therapy, Gpi

Also known as: DBS, Gpi, Activa Therapy

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Functional Neurosurgery

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 27, 2007
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

US (1)