Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT06998420
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2025-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain recurrence (BNI≥Ⅲ)', 'timeFrame': 'Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)', 'description': 'BNI Pain Intensity Scale Score:\n\nI:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief'}, {'measure': 'Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III)', 'timeFrame': '3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).', 'description': 'BNI Pain Intensity Scale Score:\n\nI:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief'}, {'measure': 'Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)', 'timeFrame': '3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).'}], 'secondaryOutcomes': [{'measure': 'Mild sensory abnormalities (BNI sensory score Grade II)', 'timeFrame': '3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).', 'description': 'BNI Pain Intensity Scale Score:\n\nI:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief'}, {'measure': 'Diplopia or hearing loss (rare complications to be recorded)', 'timeFrame': '3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).'}, {'measure': 'Postoperative infection (puncture site/intracranial)', 'timeFrame': '3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).'}, {'measure': 'Psychological status (change in HADS score)', 'timeFrame': '3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).', 'description': 'he HADS (Hospital Anxiety and Depression Scale) is a self-assessment questionnaire used to screen for anxiety (HADS-A) and depression (HADS-D) in patients, with each subscale ranging from 0 (no symptoms) to 21 (severe symptoms). A score ≥8 on either subscale suggests clinically significant symptoms.\n\nKey features:\n\n14 items (7 for anxiety, 7 for depression)\n\nSimple \\& fast (takes \\~5 min)\n\nDesigned for non-psychiatric medical settings\n\nExample scoring:\n\n0-7: Normal\n\n8-10: Mild\n\n11-14: Moderate\n\n15-21: Severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigeminal neuralgia', 'PCGG', 'poor prognosis', 'Clinical Prediction Model'], 'conditions': ['Trigeminal Neuralgia (TN)']}, 'descriptionModule': {'briefSummary': "This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:\n\n1. What factors are associated with adverse postoperative outcomes?\n2. What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent PCGG surgery at the Pain Department of Affiliated Hospital of Nantong University between 2022 and 2024 and were willing to participate in postoperative follow-up were selected as the study subjects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Diagnosed with primary trigeminal neuralgia and underwent PBCG at the Pain Department of Affiliated Hospital of Nantong University\n2. Age ≥18 years\n3. Willing to complete postoperative follow-up\n\nExclusion criteria:\n\n1. Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis)\n2. Previous interventional treatments for trigeminal neuralgia\n3. Incomplete follow-up data\n4. General anesthesia contraindications or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment'}, 'identificationModule': {'nctId': 'NCT06998420', 'briefTitle': 'Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Nantong University'}, 'officialTitle': 'Construction of a Clinical Prediction Model for Poor Prognosis Following Percutaneous Balloon Compression of the Trigeminal Ganglion', 'orgStudyIdInfo': {'id': '2024-K098-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '211600', 'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Nantong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}