Humanitarian Device Exemption

• Conditions: Dystonia

• Registration Number: NCT00580658
• Lead Sponsor: Vanderbilt University Medical Center

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 Timeline

• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-22
• Study First Posted: 2007-12-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States