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

November 25, 2022 updated by: FARO T. OWIESY, M.D

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

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Corona, California, United States, 92879
        • Corona Doctors Medical Clinics Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

٠patients suffering from episodic and chronic cluster headaches

Description

Inclusion Criteria:

- Cluster headache

Exclusion Criteria:

  • Malignant hypertension,
  • Brain tumors,
  • Cerebral vascular abnormalities,
  • Presence of a brain or nerve electro stimulator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Presentation by poster, article, and on-demand providing the data

IPD Sharing Time Frame

6-9 months

IPD Sharing Access Criteria

scientific, clinicians, national and international sources. No limitations

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Study Data/Documents

  1. Clinical Study Report
    Information identifier: Cluster Headaches-Neuroma
    Information comments: Data access on-demand only by research clinician and participating individuals
  2. Statistical Analysis Plan
    Information identifier: Cluster Headaches-Neuroma
    Information 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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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

Clinical Trials on Minimal surgical exploration for a neuroma

3
Subscribe