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The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache

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ClinicalTrials.gov Identifier: NCT04845451
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
FARO T. OWIESY, M.D, Corona Doctors Medical Clinics, Inc.

Study Description
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Brief Summary:

Role of a neuroma of zygomatic-temporal in triggering of a cluster headache. Exploratory diagnosis, resection, and pathological examination of tumor anticipated

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Condition or disease Intervention/treatment
Cluster Headaches and Other Trigeminal Autonomic Cephalgias Other: Minimal surgical exploration for a neuroma

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:

  1. Zygomatico-Temporal-neuroma
  2. Zygomatic nerve V-II
  3. Intraorbital communicants rami
  4. Lacrimal nerve V-I
  5. 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
  6. Optic nerve via ophthalmic nerve routing and electricity propagation.
  7. 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 Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache: Resection of a Neuroma in the Long-term Resolution of Trigeminal Cluster Symptoms
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : September 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Groups and Cohorts
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Intervention Details:
  • Other: Minimal surgical exploration for a neuroma
    Orientation marking of the trigger point by injectable sterile methylene blue dye 0.1ml. Marking a 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.
    Other Name: Clusterotomy

Outcome Measures
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Primary Outcome Measures :
  1. Presence of Neuroma [ Time Frame: 6 months ]
    Zygomaticotemporal neuroma as trigger of Episodic and Chronic Cluster headache

  2. Resolution of Cluster Headache attacks [ Time Frame: 6 months ]
    Resection of a ZT-neuroma may eradicate Cluster Headache trigger


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with a diagnosis of episodic chronic Cluster Headaches
Criteria

Inclusion Criteria: Episodic Chronic Cluster Headaches -

Exclusion Criteria:

Malignant hypertension, Brain tumors, brain vascular abnormalities

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845451


Contacts
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Contact: FARO T OWIESY, M.D. 9513719500 owiesymd@gmail.com
Contact: FARO t OWIESY, M.D. 9513719500 fowiesy02@aol.com

Locations
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United States, California
Corona Doctors Medical Clinics Inc Recruiting
Corona, California, United States, 92879
Contact: Faro T Owiesy    951-371-9500    owiesymd@gmail.com   
Contact: Jovana Martin Murillo    9513719500    coronadoctors@aol.com   
Principal Investigator: Faro T Owiesy, MD         
Sponsors and Collaborators
Corona Doctors Medical Clinics, Inc.
Investigators
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Principal Investigator: Faro T Owiesy, M.D. CORONA DOCTORS MEDICAL CLINICS
More Information
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Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: Cluster Headaches-Neuroma
Data access on-demand only by research clinician and participating individuals
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: Cluster Headaches-Neuroma
Data access on-demand only by research clinician and participating individuals

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Responsible Party: FARO T. OWIESY, M.D, Faro Ted Owiesy, M.D., Corona Doctors Medical Clinics, Inc.
ClinicalTrials.gov Identifier: NCT04845451    
Other Study ID Numbers: CoronaDMC
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Presentation by poster, article, and on-demand providing the data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6-9 months
Access Criteria: scientific, clinicians, national and international sources. No limitations
Keywords provided by FARO T. OWIESY, M.D, Corona Doctors Medical Clinics, Inc.:
Trigeminal nerve neuroma, cluster headache
Additional relevant MeSH terms:
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Neuroma
Cluster Headache
Trigeminal Autonomic Cephalalgias
Headache
Pain
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms