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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT00580658
Other study ID # 060155
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information

Verified date October 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
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
Est. completion date
Est. primary completion date
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.

Study Design


Related Conditions & MeSH terms


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, 

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