Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT06278194
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Masseter muscle thickness', 'timeFrame': 'Pre-procedural time', 'description': 'The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.'}, {'measure': 'Masseter muscle thickness', 'timeFrame': 'Post-procedural first month', 'description': 'The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.'}, {'measure': 'Masseter muscle thickness', 'timeFrame': 'Post-procedural third month', 'description': 'The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigeminal Neuralgia', 'Gasserian Ganglion; Lesion']}, 'descriptionModule': {'briefSummary': 'Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.\n\nThe radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.\n\nIn theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain refractory to medical therapy for at least 3 months\n* Planning radiofrequency thermocoagulation of gasserian ganglion\n* Accept ultrasound measurements to be performed\n\nExclusion Criteria:\n\n* Refused to participate in the study\n* Not attending follow-ups regularly\n* Coagulation disorder\n* Pregnancy\n* Localized or systemic infection'}, 'identificationModule': {'nctId': 'NCT06278194', 'briefTitle': 'Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment', 'orgStudyIdInfo': {'id': '22.11.2023.589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients treated with gasserian ganglion RFT for trigeminal neuralgia', 'description': 'In patients who have undergone radiofrequency thermocoagulation (RFT) of the gasserian ganglion for the treatment of trigeminal neuralgia, the thickness of the masseter muscle will be measured bilaterally, free and contracted, by ultrasound on the day of the procedure (just before the procedure) and at 1 and 3 months after the procedure.', 'interventionNames': ['Procedure: Gasserian Ganglion Radiofrequency Thermocoagulation']}], 'interventions': [{'name': 'Gasserian Ganglion Radiofrequency Thermocoagulation', 'type': 'PROCEDURE', 'description': 'Gasserian ganglion radiofrequency thermocoagulation is performed in the operating room under fluoroscopy. In sterile condition, the foramen ovale is shown by the pain management specialist under fluoroscopy guidance. After this condition, the entry of the needle is marked and anaesthetised with local anaesthetic. After the entry of the gasserian ganglion with the radiofrequency needle, 10 cm long, the location is checked with sensory and motor stimulation. If the placement is correct, 70 degrees 70 seconds of radiofrequency thermocoagulation is applied.', 'armGroupLabels': ['Patients treated with gasserian ganglion RFT for trigeminal neuralgia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Başakşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Burak Erken, Medical Doctor', 'role': 'CONTACT', 'email': 'burak_erken@hotmail.com', 'phone': '+0902129096000'}, {'name': 'Tuba Tanyel Saraçoğlu, MD', 'role': 'CONTACT', 'email': 'tuba.saracoglu1@saglik.gov.tr'}, {'name': 'Tuba Tanyel Saraçoğlu, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Başakşehir Çam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Burak Erken, MD', 'role': 'CONTACT', 'email': 'burak_erken@hotmail.com', 'phone': '+0902129096000'}], 'overallOfficials': [{'name': 'Tuba Tanyel Saraçoğlu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Başakşehir Çam & Sakura City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Burak Erken', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}