Humanitarian Device Exemption (Dystonia IRB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00580658|
Expanded Access Status : Approved for marketing
First Posted : December 27, 2007
Last Update Posted : October 14, 2019
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|Condition or disease||Intervention/treatment|
|Dystonia||Device: Medtronic Activa Gpi|
|Study Type :||Expanded Access|
|Official Title:||Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy|
- Device: Medtronic Activa Gpi
Activa Therapy, GpiOther Names:
- Activa Therapy
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, Learn About Clinical Studies.
|Ages Eligible for Study:||7 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580658
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Peter E Konrad, MD, Ph.D.||Vanderbilt University, Dept. Neurosurgery|
|Principal Investigator:||Dario Englot, MD PhD||Vanderbilt University, Dept. Neurosurgery|
|Principal Investigator:||Thomas L Davis, MD||Vanderbilt University, Dept. Neurology|
|Principal Investigator:||John Y Fang, MD||Vanderbilt University, Dept. Neurology|
|Responsible Party:||Peter Konrad, Professor, Director of Functional Neurosurgery, Vanderbilt University|
|Other Study ID Numbers:||
|First Posted:||December 27, 2007 Key Record Dates|
|Last Update Posted:||October 14, 2019|
|Last Verified:||October 2019|
Nervous System Diseases
Central Nervous System Diseases