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NCT00580658: Dystonia IRB
Humanitarian Device Exemption
trial testing Medtronic Activa Gpi in Dystonia. Approved for marketing.
Quick facts
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
| Sites | 1 location across United States |
Drugs / interventions tested
- Medtronic Activa Gpi
Conditions studied
- Dystonia — all drugs for Dystonia →
Sponsor
Vanderbilt University Medical Center
Who can join
7 and older, any sex, with Dystonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
Verify or expand the search:
- PubMed search for NCT00580658
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dystonia
Currently open trials in the same condition.
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
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- NCT07190092 — Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment. · NA · recruiting
- NCT07244549 — Chronic Outcome Monitoring for DBS in Dystonia · recruiting
- NCT06585618 — A Multicenter Pediatric Deep Brain Stimulation Registry · recruiting
Other Vanderbilt University Medical Center trials
Trials by the same sponsor.
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- NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00580658 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
- Last refreshed: 14 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00580658.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing