Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-31 @ 2:22 AM
Study NCT ID:
NCT01975532
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Diffusion MRI as a Tool in Planning Deep Brain Stimulation (DBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-04', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UPDRS (unified parkinson disease rating scale) score', 'timeFrame': 'patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months'}], 'secondaryOutcomes': [{'measure': 'Cognitive scores on neuropsychological exam', 'timeFrame': 'patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Movement Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients screened and deemed eligible for treatment with Deep Brain Stimulation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Deep Brian Stimulation surgery\n\nExclusion Criteria:\n\n* DBS treatment stopped before 12 month followup'}, 'identificationModule': {'nctId': 'NCT01975532', 'briefTitle': 'Evaluation of Diffusion MRI as a Tool in Planning Deep Brain Stimulation (DBS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Evaluation of MRI Based Fiber Tracking as a Tool in Deep Brain Stimulation for Movement Disorders', 'orgStudyIdInfo': {'id': '26-MRI-DTI-on-DBS'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mikkel Petersen, phd-student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}