Clinical trialNCT00580658Approved, for, marketingExpanded Access

Humanitarian Device Exemption

SponsorVanderbilt University Medical CenterDystonia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Dario Englot, MD PhD
Vanderbilt University, Dept. Neurosurgery
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
John Y Fang, MD
Vanderbilt University, Dept. Neurology
Principal Investigator
clinicaltrials.gov ↗
Peter E Konrad, MD, Ph.D.
Vanderbilt University, Dept. Neurosurgery
Principal Investigator
clinicaltrials.gov ↗
Thomas L Davis, MD
Vanderbilt University, Dept. Neurology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Vanderbilt University
Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: —
Primary completion: —
Completion: —
Last update posted: 14 Oct 2019
Registered enrollment: —
Registry id: NCT00580658

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.