Humanitarian Device Exemption

Dystonia Clinical Trial

— Dystonia IRB  

Official title:

Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00580658
• Other study ID #: 060155
• Status: Approved for marketing

Study information

• Verified date: October 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Intervention

Device:
• Medtronic Activa Gpi
Activa Therapy, Gpi

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States,