Clinical Trial 45936

Corona, CA 92879


Summary:

 

Our study projects evidence of zygomaticotemporal neuroma as a triggering source of the ECCH. Surgical exploration and resection of this subject may cure in long term the ECCH. It may eradicate puzzling questions and treatments, saving a life, easing the  psycho-social and financial  burden on individual patients and society

The procedure is very simple and easy in the hand of an experienced surgeon. No need for the reconstructive procedure. A pathologic examination of resected minimal suspected tissue is imperative and may increase clinical confidence of the goal. 



Eligibility:

Ages Eligible for Study:   20 Years to 70 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Inclusion Criteria:

Age: 20-70 years

Ability to distinguish Cluster Headaches attacks as discrete from other headaches (i.e., tension-headache, migraine HA)

Ability to read, comprehend, and legibly and reliably record information

Ability to provide written, informed consent, and respond to pre and post-treatment questionnaires

Already on abortive and other off-label medications and psychedelics.

Exclusion Criteria:

Uncontrollable malignant  hypertension

History of stroke, TIA, or epilepsy

History of a brain aneurysm, implantation of Neurostimulation, trigeminal tractotomy, Neurectomy

Hypersensitivity, or contraindications to Lidocaine.

Contraindication : None

 


Qualified Participants May Receive:

A detailed interview, review of medical records, and medications. By matching our study criteria patients will be scheduled for a  mini surgical intervention at our clinic with the following expected outcome:

Primary Outcome Measures:

The primary efficacy parameter will be whether or not a patient with cluster headache exhibits the presence of a  Neuroma of the zygomaticotemporal nerve at the affected side. Its excision provides resolution of clusters of headaches during the next 6 months after the diagnosis and procedure.

Secondary Outcome Measures:

Exhibition of development of the extraordinary novel approach in the treatment of debilitating Cluster headaches occurrence.

Secondary Outcome Measures:

  • Impact of therapeutic minimal surgical intervention on the prevalence and clinical course of Cluster Headache in patients with a history of inconsequent pharmaceutical and divisive therapy.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.