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

NCT04845451 | Completed DMC

• 1 other identifier: CoronaDMC
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cluster Headache; Craniofacial Pain Syndrome

Keywords

cluster headache; neuralgic headache

Outcome Measures

Primary Outcomes (2)

• Presence of Neuroma

  Zygomaticotemporal neuroma as trigger of Episodic and Chronic Cluster headache

  6 months

• Resolution of Cluster Headache attacks

  Resection of a ZT-neuroma may eradicate Cluster Headache trigger

  6 months

Interventions

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.

Also known as: Clusterotomy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

٠patients suffering from episodic and chronic cluster headaches

You may qualify if:

• \- Cluster headache

You may not qualify if:

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

Sponsors & Collaborators

• FARO T. OWIESY, M.D: lead
• Ohsi, Steven, M.D: collaborator
• Radfar, Amir, M.D: collaborator

Study Sites (1)

Corona Doctors Medical Clinics Inc

Corona, California, 92879, United States

Location

MeSH Terms

Conditions

Cluster Headache; Facial Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Study Officials

• Faro T Owiesy, M.D.

  CORONA DOCTORS MEDICAL CLINICS

  PRINCIPAL INVESTIGATOR

• Steven Ohsie, M.D

  Affiliated Patholgy

  STUDY CHAIR

• Amir Radfar, M.D,MPH

  Corona doctors medical clinics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 15, 2021
• Study Start: June 9, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6-9 months
• Access Criteria: scientific, clinicians, national and international sources. No limitations

Locations

US (1)