Humanitarian Device Exemption (Dystonia IRB)

Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy

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.

Study Overview

• Status: Approved for marketing
• Conditions: Dystonia
• Intervention / Treatment: Device: Medtronic Activa 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.

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• 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

Study record dates

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 22, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: DBS; Dystonia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders
• Other Study ID Numbers: 060155