Cluster HeadacheNCT04845451
The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache
An observational study of Cluster Headache and Craniofacial Pain Syndrome, run by FARO T. OWIESY, M.D at 1 site in United States.
Trial summary
Role of a neuroma of zygomatic-temporal in triggering of a cluster headache. Exploratory diagnosis, resection, and pathological examination of tumor anticipated . Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cluster Headache, Craniofacial Pain Syndrome
- What is being tested?
- Minimal surgical exploration for a neuroma
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ٠patients suffering from episodic and chronic cluster headaches
Who may be able to join
- Cluster headache
Who cannot join
- Malignant hypertension,
- Brain tumors,
- Cerebral vascular abnormalities,
- Presence of a brain or nerve electro stimulator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Corona Doctors Medical Clinics Inc
Corona, California, 92879
About this study
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
Role of a neuroma of zygomatic-temporal in triggering of a cluster headache. Exploratory diagnosis, resection, and pathological examination of tumor anticipated
.
Read the 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:
- 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.
- Conditions
- Cluster Headache, Craniofacial Pain Syndrome
- Being tested
- Minimal surgical exploration for a neuroma
- Keywords
- cluster headache, neuralgic headache
- Medical subject headings
- Cluster Headache, Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal surgical exploration for a neuromaOther
Also called Clusterotomy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Neuroma
Zygomaticotemporal neuroma as trigger of Episodic and Chronic Cluster headache
Measured: 6 months
Resolution of Cluster Headache attacks
Resection of a ZT-neuroma may eradicate Cluster Headache trigger
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start9 Jun 2021
- Primary completion30 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- FARO T. OWIESY, M.D
- Sponsor type
- University, hospital or other
- Collaborators
- Ohsi, Steven, M.D, Radfar, Amir, M.D
- Responsible party
- Sponsor-investigator, FARO T. OWIESY, M.D, Corona Doctors Medical Clinics, Inc.
- Investigators
- Faro T Owiesy, M.D., Principal investigator, CORONA DOCTORS MEDICAL CLINICSSteven Ohsie, M.D, Study chair, Affiliated PatholgyAmir Radfar, M.D,MPH, Study director, Corona doctors medical clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845451
- Sponsor's protocol ID
- CoronaDMC
- Status last verified
- Nov 2022
- First submitted
- 10 Apr 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Presentation by poster, article, and on-demand providing the data
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04845451
- Acronym / sponsor ID
- CoronaDMC
- Conditions
- Cluster Headache, Craniofacial Pain Syndrome
- Keywords
- cluster headache, neuralgic headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- FARO T. OWIESY, M.DUniversity, hospital or other
- Collaborators
- Ohsi, Steven, M.D, Radfar, Amir, M.D
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Role of a neuroma of zygomatic-temporal in triggering of a cluster headache. Exploratory diagnosis, resection, and pathological examination of tumor anticipated
.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ٠patients suffering from episodic and chronic cluster headaches
Key inclusion criteria (1 listed)
- Cluster headache
Key exclusion criteria (4 listed)
- Malignant hypertension,
- Brain tumors,
- Cerebral vascular abnormalities,
- Presence of a brain or nerve electro stimulator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal surgical exploration for a neuromaAlso: ClusterotomyOrientation 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 | – |
Primary outcome
Presence of Neuroma
Time frame: 6 months
Zygomaticotemporal neuroma as trigger of Episodic and Chronic Cluster headache
Resolution of Cluster Headache attacks
Time frame: 6 months
Resection of a ZT-neuroma may eradicate Cluster Headache trigger
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Yes. Presentation by poster, article, and on-demand providing the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faro T Owiesy, M.D. principal investigator
CORONA DOCTORS MEDICAL CLINICS
Steven Ohsie, M.D study chair
Affiliated Patholgy
Amir Radfar, M.D,MPH study director
Corona doctors medical clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache and Craniofacial Pain Syndrome, run by FARO T. OWIESY, M.D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Neuroma (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.