Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-12 @ 10:59 PM
Study NCT ID:
NCT00580658
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2019-10-14
First Post:
2007-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humanitarian Device Exemption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004421', 'term': 'Dystonia'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2019-10', 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2007-12-13', 'studyFirstSubmitQcDate': '2007-12-22', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Dystonia', 'DBS'], 'conditions': ['Dystonia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients whose ages are in the range of 7 and 99 years old\n* 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.\n* Patients who have failed appropriate medical therapy as determined by the SMD conference\n\nExclusion Criteria:\n\n* Patients younger than 7 years old\n* Patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist.\n* Patients who have not had an adequate trial of medical or non-surgical therapy as determined by the SMD conference.\n* Patients not deemed good candidates by the SMD conference group.'}, 'identificationModule': {'nctId': 'NCT00580658', 'acronym': 'Dystonia IRB', 'briefTitle': 'Humanitarian Device Exemption', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy', 'orgStudyIdInfo': {'id': '060155'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medtronic Activa Gpi', 'type': 'DEVICE', 'otherNames': ['DBS', 'Gpi', 'Activa Therapy'], 'description': 'Activa Therapy, Gpi'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Peter E Konrad, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University, Dept. Neurosurgery'}, {'name': 'Dario Englot, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University, Dept. Neurosurgery'}, {'name': 'Thomas L Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University, Dept. Neurology'}, {'name': 'John Y Fang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University, Dept. Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of Functional Neurosurgery', 'investigatorFullName': 'Peter Konrad', 'investigatorAffiliation': 'Vanderbilt University'}}}}