Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-10 @ 2:14 PM
Study NCT ID:
NCT06494956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004343', 'term': 'Drug Implants'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-07', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-07-07', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary", 'timeFrame': '7 months', 'description': 'Subjects fill in diary cards'}, {'measure': 'Subjects fill in a diary card after device implantation', 'timeFrame': '6 months', 'description': 'Subjects fill in diary cards'}, {'measure': 'Drug dosage evaluation', 'timeFrame': '7 months', 'description': 'Subjects fill in diary cards'}, {'measure': 'Charging performance evaluation', 'timeFrame': '6 months', 'description': 'Subjects fill in diary cards'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease Dementia']}, 'descriptionModule': {'briefSummary': "To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease", 'detailedDescription': "To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1. Aged 18-70 years old, patients with primary Parkinson\'s disease;2. The duration of Parkinson\'s disease is 5 years or more;3. The stage of Hoehn-Yahr in the "off" (without medication) state is 2 or more stages;4. UPDRS motion score ≥30 in "Off" state;5. Good response to dopamine drugs, acute levodopa experiment UPDRS exercise score improvement rate of more than 30% (experimental drug Medoba 250mg);6. The daily drug shutdown period is at least 6 hours, or there are sports complications such as serious transactions, and repeated adjustments of drugs still cannot be effectively improved;7. MMSE score ≥24 points on the simple intelligent mental state Examination Scale;8. Have the ability of independent external charging operation;9. Patients or their family members can fully understand the treatment and sign informed consent;10. The patient had good compliance and was able to meet the requirements of postoperative follow-up.\n\nExclusion Criteria:1. Have received surgical treatment for Parkinson\'s disease other than deep brain stimulation, such as stereotactic destruction, cell transplantation, gamma knife, etc.;2. The "off" state has serious language disorders, dysphagia, balance disorders and other midline symptoms;3. There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, ventricle enlargement, cerebrovascular sequelae, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases;4. Have other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other neurostimulator, or need to undergo frequent magnetic examinations;5. Patients who are abnormally sensitive to temperature or allergic to heat;6. There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indicators exceeding three times the normal value).7. Patients with anxiety and depression.'}, 'identificationModule': {'nctId': 'NCT06494956', 'briefTitle': "To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu CED Medtech Co., Ltd'}, 'officialTitle': "A Prospective, Single-center, Open Clinical Study to Evaluate the Safety of Implantable Rechargeable Computerized Deep Nerve Stimulation Systems in Patients With Primary Parkinson's Disease", 'orgStudyIdInfo': {'id': 'CER-A-PG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single unit', 'description': 'An implantable computer fills the deep nervous system and turns it on for treatment', 'interventionNames': ['Procedure: Implant device']}], 'interventions': [{'name': 'Implant device', 'type': 'PROCEDURE', 'description': 'A subcutaneous tunnel was established under general anesthesia, the electrode was connected to the stimulator, and the pulse generator was implanted in the skull.', 'armGroupLabels': ['Single unit']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu CED Medtech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}