Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-25 @ 2:02 PM
Study NCT ID:
NCT07190092
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract.', 'timeFrame': '6 weeks', 'description': 'Increase of FMA score after the rehabilitation'}], 'secondaryOutcomes': [{'measure': 'Decrease of Ashworth Scale score after the rehabilitation with dentate-rubro-thalamic tract', 'timeFrame': '6 weeks', 'description': 'Decrease of Ashworth Scale score'}, {'measure': 'Improvement in motor function achieves in Motor Assessment Scale MAS with stimulation dentate-rubro-thalamic tract', 'timeFrame': '6 weeks', 'description': 'Improvement in motor function achieves in Motor Assessment Scale'}, {'measure': 'Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract', 'timeFrame': '6 weeks', 'description': 'Improvement in Modified Rankin Scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dentate nucleus', 'DRTt', 'dentate-rubro-thalamic tract', 'deep brain stimulation', 'post-stroke spasticity', 'rehabilitation'], 'conditions': ['Post Stroke Spasticity', 'Dystonia']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to determine whether deep brain stimulation (DBS) interventions improve rehabilitation and functional recovery in patients with post-stroke spasticity who meet the other inclusion criteria listed below.\n\nPrimary question(s) to be answered:\n\nIs DBS stimulation effective in treating post-stroke spasticity? What stimulation frequency is most effective in treating post-stroke spasticity?\n\nStudy participants will:\n\n* Undergo surgery to implant a DBS electrode targeting the DRTt (dentate-rubro-thalamic tract ) in close proximity of the dentate nucleus of the cerebellum ipsilateral to the spastic side of the body.\n* Each patient will then receive an initial stimulation frequency of 130 Hz (arm 1) and will be assigned to a 4- to 6-week rehabilitation program. After this period, the participant will return for a follow-up visit for a clinical evaluation.\n* The frequency will then be changed to 70Hz (arm 2). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks. After this period, they will return to the Clinic for a follow-up evaluation.\n* The frequency will then be changed to 30Hz (arm 3). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks.\n\nResearchers will compare the results obtained from patients in each arm to determine the clinical effects of stimulation and whether they are dependent on the stimulation frequency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One time stroke that occurred 9-36 months ago\n* Ischemic or hemorrhagic stroke\n* Spastic paresis of at least one limb\n* At least 3 months of poststroke rehabilitation in the past\n* No improvement of spasticity/motor function for at least 3 months\n\nExclusion Criteria:\n\n* Seizures after the stroke\n* Depression\n* Severe sensory deficits\n* Anosognosia\n* Moderate to severe hemispatial neglect\n* Others contraindications for the DBS procedure, e.g. coagulopathy, decompensated chronic disease, etc.\n* Contraindication for MRI\n* No poststroke rehabilitation'}, 'identificationModule': {'nctId': 'NCT07190092', 'briefTitle': 'Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.', 'organization': {'class': 'OTHER', 'fullName': 'Jan Biziel University Hospital No 2 in Bydgoszcz'}, 'officialTitle': 'Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.', 'orgStudyIdInfo': {'id': 'KB 314/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-frequency stimulation', 'description': 'Patients in this arm of the study will undergo implantation of deep brain stimulation electrodes. The stimulation parameters will include a frequency of 130 Hz, which differentiates this arm from the others. The study duration will be four weeks. At the beginning and end of participation in this arm, patients will be examined and assessed using the previously discussed scales.', 'interventionNames': ['Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus']}, {'type': 'EXPERIMENTAL', 'label': 'Low-frequency stimulation', 'description': 'Patients in this arm of the study will have deep brain stimulation electrodes implanted. Stimulation parameters will include a frequency of 50 Hz, which differentiates this arm from the others. The study duration will be four weeks. At the beginning and end of participation in this arm, patients will be examined and assessed using the previously discussed scales.', 'interventionNames': ['Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus']}, {'type': 'SHAM_COMPARATOR', 'label': 'No stimulation', 'description': 'Patients participating in this arm of the study will have deep brain stimulation electrodes implanted. The stimulation will be turned off. The study will last four weeks. At the beginning and end of their participation in this arm, patients will be assessed and rated using the scales discussed earlier.', 'interventionNames': ['Procedure: Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus']}], 'interventions': [{'name': 'Deep brain stimulation electrode implantation with an electrode target in the dentate nucleus', 'type': 'PROCEDURE', 'description': 'The intervention will involve implantation of a directional electrode with a target in the dentate nucleus of the cerebellum, ipsilateral to the limbs affected by spasticity. Electrode implantation will be performed using a stereotaxic frame, following prior planning of the electrode trajectory and tractography of the dento-ruborothalamic tract using a planning station. The procedure will be performed under general anesthesia. The IPG stimulator will be placed in the subclavicular region.', 'armGroupLabels': ['High-frequency stimulation', 'Low-frequency stimulation', 'No stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-168', 'city': 'Bydgoszcz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Paweł Sokal, Ph.D.', 'role': 'CONTACT', 'email': 'pawel.sokal@cm.umk.pl', 'phone': '+48600954415'}, {'name': 'Magdalena Jabłońska, M.D.', 'role': 'CONTACT', 'email': 'magdalena.jablonska14@gmail.com', 'phone': '+48 784 019 156'}, {'name': 'Magdalena Jabłońska, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oskar Puk, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paweł Sokal, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'centralContacts': [{'name': 'Paweł Sokal, Ph.D.', 'role': 'CONTACT', 'email': 'pawel.sokal@cm.umk.pl', 'phone': '+48600954415'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jan Biziel University Hospital No 2 in Bydgoszcz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Neurosurgery and Neurology', 'investigatorFullName': 'Pawel Sokal', 'investigatorAffiliation': 'Jan Biziel University Hospital No 2 in Bydgoszcz'}}}}