- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04845451
The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache
The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache: Resection of a Neuroma in the Long-term Resolution of Trigeminal Cluster Symptoms
Role of a neuroma of zygomatic-temporal in triggering of a cluster headache. Exploratory diagnosis, resection, and pathological examination of tumor anticipated
.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Poor attention to the characterization of a peripheral neuroma of trigeminal nerve branch deranged attention to central(CNS) characterization of Cluster Symptoms.
This 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.
The extracranial circuit components of ECCH reflects the anatomical nerve components participating reflection of the single circumscribed symptom:
- Zygomatico-Temporal-neuroma
- Zygomatic nerve V-II
- Intraorbital communicants rami
- Lacrimal nerve V-I
- 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
- Optic nerve via ophthalmic nerve routing and electricity propagation.
- Pterygopalatine ganglion as peripheral and CNS coordinator center.
An intracranial CNS reaction follows in response to the perception of pain materialized in neuroimaging during the activity of ECCH.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Corona, California, United States, 92879
- Corona Doctors Medical Clinics Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cluster headache
Exclusion Criteria:
- Malignant hypertension,
- Brain tumors,
- Cerebral vascular abnormalities,
- Presence of a brain or nerve electro stimulator.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of Neuroma
Time Frame: 6 months
|
Zygomaticotemporal neuroma as trigger of Episodic and Chronic Cluster headache
|
6 months
|
Resolution of Cluster Headache attacks
Time Frame: 6 months
|
Resection of a ZT-neuroma may eradicate Cluster Headache trigger
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Faro T Owiesy, M.D., Corona doctors medical clinics
- Study Chair: Steven Ohsie, M.D, Affiliated Patholgy
- Study Director: Amir Radfar, M.D,MPH, Corona doctors medical clinics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Mouth Diseases
- Neoplasms, Nerve Tissue
- Cranial Nerve Diseases
- Headache Disorders, Primary
- Headache Disorders
- Nerve Sheath Neoplasms
- Facial Nerve Diseases
- Trigeminal Autonomic Cephalalgias
- Headache
- Facial Neuralgia
- Facial Pain
- Neuroma
- Cluster Headache
Other Study ID Numbers
- CoronaDMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Study Data/Documents
-
Clinical Study Report
Information identifier: Cluster Headaches-NeuromaInformation comments: Data access on-demand only by research clinician and participating individuals
-
Statistical Analysis Plan
Information identifier: Cluster Headaches-NeuromaInformation comments: Data access on-demand only by research clinician and participating individuals
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cluster Headache
-
Diamond Headache ClinicGlaxoSmithKlineUnknownEpisodic Cluster Headache | Chronic Cluster HeadacheUnited States
-
Eli Lilly and CompanyCompletedEpisodic Cluster Headache | Chronic Cluster HeadacheSpain, United States, Finland, Germany, United Kingdom, Belgium, France, Denmark, Italy, Netherlands, Canada, Greece
-
Winston LaboratoriesNot yet recruitingEpisodic Cluster Headache
-
Man and Science, SARecruitingChronic Cluster HeadacheBelgium
-
Radboud University Medical CenterLeiden University Medical Center; ZonMw: The Netherlands Organisation for Health... and other collaboratorsNot yet recruitingChronic Cluster Headache
-
Leiden University Medical CenterUniversity of Copenhagen; Maastricht University Medical Center; Erasmus Medical... and other collaboratorsCompletedChronic Cluster HeadacheNetherlands, Belgium, Germany, Hungary
-
Hospices Civils de LyonNot yet recruitingCluster Headache, Episodic
-
H. Lundbeck A/SCompletedCluster Headache, EpisodicSpain, United States, Germany, Portugal, Italy, Netherlands, Finland, Belgium, Czechia, Denmark, France, Georgia, Russian Federation, United Kingdom, Greece, Estonia, Japan, Norway, Sweden
-
Teva Branded Pharmaceutical Products R&D, Inc.TerminatedEpisodic Cluster HeadacheUnited States, Australia, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, Canada
-
Eli Lilly and CompanyCompletedEpisodic Cluster HeadacheItaly, United States, Canada, Belgium, Denmark, Finland, France, Germany, Spain, United Kingdom, Netherlands, Greece
Clinical Trials on Minimal surgical exploration for a neuroma
-
Hospices Civils de LyonCompletedGender Dysphoria Vaginoplasty SexualityFrance
-
Wake Forest University Health SciencesNational Institute on Aging (NIA)RecruitingHemodialysis Complication | End-Stage Kidney DiseaseUnited States
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Vita CareJohnson & JohnsonRecruitingKnee Injuries | ACL Injury | Sports Injury | ACL TearBrazil
-
Zonguldak Bulent Ecevit UniversityCompleteda Survey-based StudyTurkey
-
Centre Hospitalier Régional d'OrléansWithdrawnOsteoporosis | COPD | KyphosisFrance
-
Hospices Civils de LyonRecruiting
-
Consorci Sanitari de TerrassaRecruitingRotator Cuff Injuries | Surgery | Empowerment, PatientSpain
-
University of GöttingenCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedAortic Valve Insufficiency | Aortic AneurysmFrance