Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT07231302
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stimulation of the Dentate Nucleus of the Cerebellum for the Treatment of Refractory Spasticity With or Without Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020821', 'term': 'Dystonic Disorders'}, {'id': 'D020329', 'term': 'Essential Tremor'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D001259', 'term': 'Ataxia'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DSB in the dentate nucleus', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks', 'description': 'All stereotactic image calculations the definitive location of the implants in relation to the targets proposed in the ND, were reanalyzed in a digital environment that included co-registration of the preoperative MRI, DTI, and stereotomograph'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep brain stimulation', 'Nucleus dentatus', 'Dystonia', 'Ataxia'], 'conditions': ['Ataxia - Other', 'Dystonia Disorder', 'Tremor, Essential', 'Choreatic Disorder', 'Deep Brain Stimulation Surgery']}, 'referencesModule': {'references': [{'pmid': '34513166', 'type': 'RESULT', 'citation': 'Diniz JM, Cury RG, Iglesio RF, Lepski GA, Franca CC, Barbosa ER, de Andrade DC, Teixeira MJ, Duarte KP. Dentate nucleus deep brain stimulation: Technical note of a novel methodology assisted by tractography. Surg Neurol Int. 2021 Aug 9;12:400. doi: 10.25259/SNI_338_2021. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Electrical stimulation (DBS) through electrodes implanted in the dentate nucleus of the cerebellum for the treatment of tremor intractable with medication, dystonia due to cerebrovascular disease (stroke), sequelae of traumatic brain injury, and ataxia (a disease that causes incoordination of movements). Use of advanced magnetic resonance imaging techniques and recording of nerve cell activity in this nucleus', 'detailedDescription': 'To establish anatomical and functional criteria, based on stereotactic imaging and electrophysiological recordings, that enable the precise implantation of electrodes in the DN and its efferent projections for the treatment of movement disorders. This study aims to describe a surgical technique for the implantation of deep brain electrodes targeting the stimulation (DBS) of the dentate nucleus (DN) and its efferent projections, supported by the magnetic resonance imaging (MRI), the diffusion tensor imaging (DTI), reformatted in the stereotomographic images and related to stereotactic landmarks and checked with semimicro deep brain recording.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with dystonia, ataxia or tremor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older\n2. Clinical diagnosis of cerebellar syndrome resulting from stroke and spinocerebellar degeneration, intractable tremor, primary or secondary dystonia, refractory to drug and physiotherapy treatment;\n3. Signed the term of free and informed consent\n\nExclusion Criteria:\n\n1. Age under 18 years;\n2. Presence of severe anatomical deformities in the cerebellum and/or brainstem;'}, 'identificationModule': {'nctId': 'NCT07231302', 'acronym': 'DN_DBS', 'briefTitle': 'Stimulation of the Dentate Nucleus of the Cerebellum for the Treatment of Refractory Spasticity With or Without Dystonia', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Determination of Stereotactic Landmarks Based on Computer-generated Images and Electrophysiological Recording Patterns for Electrode Implantation for Stimulation of the Dentate Nucleus and Its Fiber Projections Aiming the Treatment of Movement Disorders, Like Secondary Dystonia, Ataxia, Tremor (Essential and Symptomatic)', 'orgStudyIdInfo': {'id': '32779514.5.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Final Stereotactics coordinates in DN-DBS', 'description': 'Computational dataset', 'interventionNames': ['Other: Analytical observation']}], 'interventions': [{'name': 'Analytical observation', 'type': 'OTHER', 'description': 'Analysts observation; CT + MRI + DTI pre and post operative stereotactic coordinates - implants DBS in DN', 'armGroupLabels': ['Final Stereotactics coordinates in DN-DBS']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "There are other projects similar to this one underway. I'd like to be able to connect with other researchers and share our challenges and findings."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kleber Paiva Duarte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Kleber Paiva Duarte', 'investigatorAffiliation': 'University of Sao Paulo'}}}}