Humanitarian Device Exemption (Dystonia IRB)

Vanderbilt University Medical Center

Status

Conditions: Dystonia

Treatments: Device: Medtronic Activa Gpi

Study type: Expanded Access

Funder types: Other

Identifiers

NCT00580658

060155

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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.