Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-28 @ 10:36 PM
Study NCT ID:
NCT04845451
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2021-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2021-04-10', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Neuroma', 'timeFrame': '6 months', 'description': 'Zygomaticotemporal neuroma as trigger of Episodic and Chronic Cluster headache'}, {'measure': 'Resolution of Cluster Headache attacks', 'timeFrame': '6 months', 'description': 'Resection of a ZT-neuroma may eradicate Cluster Headache trigger'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cluster headache', 'neuralgic headache'], 'conditions': ['Cluster Headache', 'Craniofacial Pain Syndrome']}, 'referencesModule': {'availIpds': [{'id': 'Cluster Headaches-Neuroma', 'url': 'https://curemymigraine.com/', 'type': 'Clinical Study Report', 'comment': 'Data access on-demand only by research clinician and participating individuals'}, {'id': 'Cluster Headaches-Neuroma', 'url': 'https://curemymigraine.com/', 'type': 'Statistical Analysis Plan', 'comment': 'Data access on-demand only by research clinician and participating individuals'}]}, 'descriptionModule': {'briefSummary': 'Role of a neuroma of zygomatic-temporal in triggering of a cluster headache. Exploratory diagnosis, resection, and pathological examination of tumor anticipated\n\n.', 'detailedDescription': 'An anatomical coordinated communication of a Cluster Circuit turned on by Zygomatico-Temporal neuroma, a malicious possibly nontraumatic, neoplastic tissue coding and decoding itself upon autonomic release of neurotransmitter(s). Exhaustion of neurotransmitter synthesis turns out the explosions of pain-symptoms off.\n\nPoor attention to the characterization of a peripheral neuroma of trigeminal nerve branch deranged attention to central(CNS) characterization of Cluster Symptoms.\n\nThis study based on our experimental results of minimal surgical procedure to explore, diagnose and resect a Zygomatico-Temporal neuroma in the temple of patients suffering from EpisodicChronic, Cluster Headache-ECCH. The goal is to light on this speculation in a novel analysis of events to put an end to devastating catastrophic headaches. Detailed anatomical components loci of the autonomic symptoms in the cluster headache reveal the presence of an electrical neural circuit.\n\nThe extracranial circuit components of ECCH reflects the anatomical nerve components participating reflection of the single circumscribed symptom:\n\n1. Zygomatico-Temporal-neuroma\n2. Zygomatic nerve V-II\n3. Intraorbital communicants rami\n4. Lacrimal nerve V-I\n5. Ophthalmic nerve Intraorbital routing, supraorbital nerves, the upper eyelid, the conjunctiva and cornea of the eye, the nose (including the tip of the nose, except alae nasi), the nasal mucosa, the frontal sinuses. V-I\n6. Optic nerve via ophthalmic nerve routing and electricity propagation.\n7. Pterygopalatine ganglion as peripheral and CNS coordinator center.\n\nAn intracranial CNS reaction follows in response to the perception of pain materialized in neuroimaging during the activity of ECCH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '٠patients suffering from episodic and chronic cluster headaches', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Cluster headache\n\nExclusion Criteria:\n\n* Malignant hypertension,\n* Brain tumors,\n* Cerebral vascular abnormalities,\n* Presence of a brain or nerve electro stimulator.'}, 'identificationModule': {'nctId': 'NCT04845451', 'briefTitle': 'The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache', 'organization': {'class': 'OTHER', 'fullName': 'Corona Doctors Medical Clinics, Inc.'}, 'officialTitle': 'The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache: Resection of a Neuroma in the Long-term Resolution of Trigeminal Cluster Symptoms', 'orgStudyIdInfo': {'id': 'CoronaDMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Minimal surgical exploration for a neuroma', 'type': 'OTHER', 'otherNames': ['Clusterotomy'], 'description': 'Orientation marking of the trigger point by injectable sterile methylene blue dye 0.1ml. Marking a 2-3-centimeter long incision line 7 mm from the Neuroma marking on the skin. Local anesthesia using plain 2% lidocaine infiltration of the circumferential exploratory area. Sterile prep and drape in surgical fashion. Meticulous exploratory preparation of the subcutaneous tissue 20 mm at each side of the incision line. Appropriate visibility of the ZT nerve branches embedded in lipomatous and connective tissue over the temporal fascia. Exploratory visualization of the subcutaneous marked tissue by methylene blue using a binocular magnification eases visualization. Using an Adson tissue forceps with side grasping teeth, now an exploratory touch of the above and distal of the marking would deliver the hypersensitive painful Neuroma tissue for sharp excision using surgical scissors. Control of bleeding and skin closure. Sterile pressure dressing. Specimen be sent to pathologic examination.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92879', 'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Corona Doctors Medical Clinics Inc', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}], 'overallOfficials': [{'name': 'Faro T Owiesy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CORONA DOCTORS MEDICAL CLINICS'}, {'name': 'Steven Ohsie, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Affiliated Patholgy'}, {'name': 'Amir Radfar, M.D,MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corona doctors medical clinics'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6-9 months', 'ipdSharing': 'YES', 'description': 'Presentation by poster, article, and on-demand providing the data', 'accessCriteria': 'scientific, clinicians, national and international sources. No limitations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FARO T. OWIESY, M.D', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ohsi, Steven, M.D', 'class': 'UNKNOWN'}, {'name': 'Radfar, Amir, M.D', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'FARO T. OWIESY, M.D', 'investigatorAffiliation': 'Corona Doctors Medical Clinics, Inc.'}}}}