Humanitarian Device Exemption

APPROVED_FOR_MARKETING

Conditions studied: Dystonia

In brief

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.

Key facts

Study ID

NCT00580658

Run by

Vanderbilt University Medical Center

Last updated by the study team

2019-10-14

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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