Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 12:20 AM
Study NCT ID:
NCT06303960
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FM-UE scores between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's Fugl-Meyer assessment scale (FM-UE) scores for each monthly visit. FM-UE scores range from 0 to 100 and the higher scores indicated better outcome of movement."}], 'secondaryOutcomes': [{'measure': 'Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's the Arm Motor Ability Test (AMAT) for each monthly visit. AMAT scores range from 0 to 57 and the higher scores indicated better outcome of movement."}, {'measure': 'the Nine-Hole Peg Test between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit."}, {'measure': 'the Bilateral Box and Block Test between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's the Bilateral Box and Block Test for each monthly visit."}, {'measure': 'Short Form Health Survey (SF-12) between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's score of Short Form Health Survey (SF-12) for each monthly visit. SF-12 scores range from 0 to 60 and the higher scores indicated better outcome of movement."}, {'measure': 'the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's score of the EuroQol (EQ-5D) scores range from 0 to 36 for each monthly visit."}, {'measure': 'the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's score of the Beck Depression Inventory or the Beck Anxiety Inventory for each monthly visit."}, {'measure': 'nerve conduction velocity between cerebellar DBS and VNS', 'timeFrame': '12 months after device implantation', 'description': "The outcomes includes each participant's nerve conduction velocity for each monthly visit recorded by flexible electrode."}, {'measure': 'safety and feasibility of VNS and cerebellar DBS', 'timeFrame': '12 months after device implantation', 'description': 'The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemiparesis', 'Cerebellar Deep Brain Stimulation', 'VNS', 'Limb Motor Function Rehabilitation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery.\n* Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42\n* Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).\n\nExclusion Criteria:\n\n* Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4)\n* Severe cognitive impairment (Mini Mental State Examination \\< 24)'}, 'identificationModule': {'nctId': 'NCT06303960', 'briefTitle': 'Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'VNS or DBS for stroke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral Cerebellar deep brain stimulation', 'description': 'Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated bilaterally.', 'interventionNames': ['Device: Bilateral Cerebellar deep brain stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unilateral Cerebellar deep brain stimulation', 'description': 'Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated unilaterally.', 'interventionNames': ['Device: Unilateral Cerebellar deep brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Vagus Nerve Stimulation', 'description': 'Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the VNS system. 1 months later, VNS was activated unilaterally.', 'interventionNames': ['Device: Vagus Nerve Stimulation']}], 'interventions': [{'name': 'Bilateral Cerebellar deep brain stimulation', 'type': 'DEVICE', 'description': 'Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389）with electrode arrays up to 15.5 mm in length. Then bilateral stimulation was activated after 1 month post-DBS', 'armGroupLabels': ['Bilateral Cerebellar deep brain stimulation']}, {'name': 'Unilateral Cerebellar deep brain stimulation', 'type': 'DEVICE', 'description': 'Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389）with electrode arrays up to 15.5 mm in length. Then unilateral stimulation was activated after 1 month post-DBS', 'armGroupLabels': ['Unilateral Cerebellar deep brain stimulation']}, {'name': 'Vagus Nerve Stimulation', 'type': 'DEVICE', 'description': 'Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region.', 'armGroupLabels': ['Vagus Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250100', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'chao zhang', 'role': 'CONTACT', 'email': 'chao_zhang@sdu.edu.cn', 'phone': '+8613969007232'}], 'facility': 'Chao Zhang', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) could be available to other researchers by request of email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}