IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Humanitarian Device Exemption (Dystonia IRB)
This treatment has been approved for sale to the public.
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00580658
First received: December 13, 2007
Last updated: May 11, 2016
Last verified: May 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
| Dystonia | Device: Medtronic Activa Gpi |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy |
Resource links provided by NLM:
Further study details as provided by Peter Konrad, Vanderbilt University:
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2020 |
Intervention Details:
Detailed Description:
-
Device: Medtronic Activa Gpi
- DBS
- Gpi
- Activa Therapy
Activa Therapy, Gpi
Other Names:
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.
Eligibility| Ages Eligible for Study: | 7 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580658
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580658
Locations
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | Peter E Konrad, MD, Ph.D. | Vanderbilt University, Dept. Neurosurgery |
| Principal Investigator: | Hong Yu, MD | Vanderbilt University, Dept. Neurosurgery |
| Principal Investigator: | Thomas L Davis, MD | Vanderbilt University, Dept. Neurology |
| Principal Investigator: | John Y Fang, MD | Vanderbilt University, Dept. Neurology |
More Information
| Responsible Party: | Peter Konrad, Professor, Director of Functional Neurosurgery, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00580658 History of Changes |
| Other Study ID Numbers: |
060155 |
| Study First Received: | December 13, 2007 |
| Last Updated: | May 11, 2016 |
Keywords provided by Peter Konrad, Vanderbilt University:
|
Dystonia |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Dyskinesias Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
ClinicalTrials.gov processed this record on June 26, 2017