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Completed

NCT Number: NCT04845451

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

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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Completed

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Corona Doctors Medical Clinics Inc

Corona, California, 92879, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cluster headache

Exclusion criteria

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

Treatment and study plan

Minimal surgical exploration for a neuroma

Other

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.

Other names: Clusterotomy

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

FARO T. OWIESY, M.D

Other

Collaborators

  • Ohsi, Steven, M.D
  • Radfar, Amir, M.D

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2021
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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