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

Cluster Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845451
• Other study ID #: CoronaDMC
• Status: Completed
• Start date: June 9, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2022
• Source: Corona Doctors Medical Clinics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Cluster headache

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cluster Headache
• Facial Neuralgia
• Facial Pain
• Headache
• Neuroma

Intervention

Other:
• Minimal surgical exploration for a neuroma
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.

Locations

Country	Name	City	State
United States	Corona Doctors Medical Clinics Inc	Corona	California

Sponsors (3)

Lead Sponsor	Collaborator
FARO T. OWIESY, M.D	Ohsi, Steven, M.D, Radfar, Amir, M.D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Neuroma	Zygomaticotemporal neuroma as trigger of Episodic and Chronic Cluster headache	6 months
Primary	Resolution of Cluster Headache attacks	Resection of a ZT-neuroma may eradicate Cluster Headache trigger	6 months