Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-25 @ 10:46 PM
Study NCT ID:
NCT03875404
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020329', 'term': 'Essential Tremor'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tremor rating score', 'timeFrame': 'One year', 'description': 'Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor)\n\n0 = None\n\n1. = Slight.\n2. = Moderate amplitude.\n3. = Marked amplitude\n4. = Severe amplitude\n\n0 = Normal\n\n1. = Mildly abnormal.\n2. = Moderately abnormal.\n3. = Marked abnormal.\n4. = Severely abnormal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation'], 'conditions': ['Essential Tremor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor\n* Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)\n* Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.)\n* Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)\n* Pregnant"}, 'identificationModule': {'nctId': 'NCT03875404', 'briefTitle': 'Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor', 'orgStudyIdInfo': {'id': '18-010340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep Brain Stimulation subjects', 'interventionNames': ['Diagnostic Test: Functional MRI']}], 'interventions': [{'name': 'Functional MRI', 'type': 'DIAGNOSTIC_TEST', 'description': "A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.", 'armGroupLabels': ['Deep Brain Stimulation subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Erik H Middlebrooks', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erik H. Middlebrooks, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}