Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT05416905
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 365', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 90', 'timeFrame': '90 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 90 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.'}, {'measure': 'Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) difference Day 180', 'timeFrame': '180 days postoperatively compared between groups]', 'description': 'Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-motor score (BFMDRS-M) in the stimulation state from before to 180 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-M contains 4 items of 0-40 and higher scores indicate a worse outcome.'}, {'measure': 'Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Burke-Fahn-Marsden dystonia rating scale-disability score (BFMDRS-D) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BFMDRS-D contains 7 items of 0-30 and higher scores indicate a worse outcome.'}, {'measure': 'Blepharospasm disability index (BDSI) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Blepharospasm disability index (BDSI) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. BDSI contains 6 items of 0-4 (average socre) and higher scores indicate a worse outcome.'}, {'measure': 'Jankovic rating scale (JRS) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Jankovic rating scale (JRS) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. JRS contains 2 items of 0-8 and higher scores indicate a worse outcome.'}, {'measure': 'Mini-mental state examination (MMSE) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of mini-mental state examination (MMSE) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MMSE contains 30 questions of 0-30 and higher scores indicate a better outcome.'}, {'measure': 'Montreal cognitive assessment (MoCA) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Montreal cognitive assessment (MoCA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. MoCA contains 8 modules of 0-30 and higher scores indicate a better outcome.'}, {'measure': 'Hamilton depression scale (HRSD) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Hamilton depression scale (HRSD) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HRSD contains 24 items of 24-77 and higher scores indicate a worse outcome.'}, {'measure': 'Hamilton anxiety scale (HAMA) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of Hamilton anxiety scale (HAMA) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. HAMA contains 14 items of 0-56 and higher scores indicate a worse outcome.'}, {'measure': 'Medical outcomes study shortform-36 (SF-36) difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in the change of medical outcomes study shortform-36 (SF-36) in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment. SF-36 contains 8 modules of 0-100 and higher scores indicate a better outcome.'}, {'measure': 'Programming parameters difference', 'timeFrame': '365 days postoperatively compared between groups', 'description': 'Differences between the two groups in programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS treatment, including total electrical energy delivered (TEED), contact, voltage, pulse width and frequency.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Craniofacial Dystonia', 'Deep Brain Stimulation', 'Globus pallidus internus', 'Subthalamic nucleus'], 'conditions': ['Craniofacial Dystonia', 'Deep Brain Stimulation']}, 'descriptionModule': {'briefSummary': 'MEIGES is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.', 'detailedDescription': 'Evaluating therapeutic effects of GPi-DBS vs. STN-DBS on patients with idiopathic craniofacial dystonia: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The main purpose is to assess whether STN-DBS is non-inferior to GPi-DBS for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.\n\nPrimary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.\n\nSecondary endpoints: Differences between the two groups in BFMDRS-M change scores in the stimulation state from before to 90, 180 days (±14 days) after STN-DBS and GPi-DBS. Differences between the two groups in BFMDRS-D, BDSI, JRS, MMSE, MoCA, HRSD, HAMA, SF-36 and programming parameters change scores in the stimulation state from before to 365 days (±14 days) after STN-DBS and GPi-DBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult subject (male or female, 18-75 years);\n2. Diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. Cervical dystonia may be present;\n3. Treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect;\n4. Normal cognitive function with MMSE score ≥ 24;\n5. Informed consent signed.\n\nExclusion Criteria:\n\n1. Only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region;\n2. Diagnosed with other neuropsychiatric diseases(Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.);\n3. History of brain surgery;\n4. Severe depression with HRSD score ≥ 35;\n5. Contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc);\n6. Contraindications to CT or MRI scanning(claustrophobia, etc);\n7. pregnant or breastfeeding female, or has positive pregnancy test prior to randomization;\n8. Contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.);\n9. Expected lifetime \\< 12 months;\n10. Currently receiving an investigational drug or device;\n11. Other circumstances that the investigator considers unsuitable to participate in this study or that may pose a significant risk to the patient (inability to understand or comply with research procedures and follow-up, etc.)."}, 'identificationModule': {'nctId': 'NCT05416905', 'acronym': 'MEIGES', 'briefTitle': 'Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: GPi or STN', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Multicenter Evaluation of Deep Brain Stimulation for Idiopathic Craniofacial Dystonia: Globus Pallidus intErnus or Subthalamic Nucleus', 'orgStudyIdInfo': {'id': 'HX-A-2022022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STN-DBS', 'description': 'The patients in this group will be treated with STN-DBS.', 'interventionNames': ['Device: STN-DBS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GPi-DBS', 'description': 'The patients in this group will be treated with GPi-DBS.', 'interventionNames': ['Device: GPi-DBS']}], 'interventions': [{'name': 'STN-DBS', 'type': 'DEVICE', 'otherNames': ['subthalamic necleus-deep brain stimulation'], 'description': 'The patients will be treated with deep brain electrode placement of STN target under local and general anesthesia. Switching the system on: the stimulator will be switched on 3 weeks after surgery to allow time for the brain edema and "stun effect" to wear off. Postoperative medication: The subject taking medication in the past will continue the medication. If the subject with no medication before, will be required not to take medication related to dystonia.', 'armGroupLabels': ['STN-DBS']}, {'name': 'GPi-DBS', 'type': 'DEVICE', 'otherNames': ['globus pallidus internus-deep brain stimulation'], 'description': 'The patients will be treated with deep brain electrode implantation of GPi target under local and general anesthesia. Except that the surgical target was GPi, the operation process, stimulator switch-on time, and postoperative medication were the same as those in the STN-DBS group.', 'armGroupLabels': ['GPi-DBS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianguo Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zjguo73@126.com', 'phone': '+86-13601294613'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yutong Bai, MD, PhD', 'role': 'CONTACT', 'email': 'baiyutong88@qq.com', 'phone': '13611420134'}], 'overallOfficials': [{'name': 'Jianguo Zhang, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Civil Aviation General Hospital', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Beijing Pins Medical Co., Ltd', 'class': 'INDUSTRY'}, {'name': 'Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Beijing Fengtai Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Functional Neurosurgery', 'investigatorFullName': 'Jianguo Zhang', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}