Humanitarian Device Exemption (Dystonia IRB)
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ClinicalTrials.gov Identifier: NCT00580658 |
Recruitment Status
:
Approved for marketing
First Posted
: December 27, 2007
Last Update Posted
: May 13, 2016
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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 |
Study Start Date : | May 2006 |
Estimated Study Completion Date : | May 2020 |

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Device: Medtronic Activa Gpi
- DBS
- Gpi
- Activa Therapy

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Ages Eligible for Study: | 7 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
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 |
Responsible Party: | Peter Konrad, Professor, Director of Functional Neurosurgery, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00580658 History of Changes |
Other Study ID Numbers: |
060155 |
First Posted: | December 27, 2007 Key Record Dates |
Last Update Posted: | May 13, 2016 |
Last Verified: | May 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 |