Recent Advances in Clinical Trials

Open Access ISSN: 2771-9057

Abstract


Theoretical, Practical, and Clinical Aspects of a Novel Approach to the Treatment of Chronic and Episodic Cluster Headaches

Authors: Faro T. Owiesy, Steven Ohsie, Amir Radfar.

Importance: Chronic and episodic cluster headaches are a worldwide distributed problem that significantly impairs sufferers’ ability to function and perform their daily activities. Puzzling triggers and treatment approaches are burdensome and costly. A new approach to chronic and episodic cluster headaches may light up long-term and curative treatment and a new understanding of trigger(s).

Objective: The objective was to redefine the cause of the cluster headaches, diagnosing the evidence of a neuroma in the distribution of a zygomaticotemporal nerve, and the long-term symptom free resolution of cluster headaches.

Design: A single center, randomized, interventional, prospective clinical trial. Allocation is selective and ambulatory. Anticipated all gender and races aged 20-70 years old.

Primary outcome and measures: Evidence of Neuroma by histopathologic examination, long-term efficacy in relieving cluster headaches over 270 days. We were looking at other possible correlating findings. An interventional prospective clinical trial per protocol; clinicaltrial.gov Identifier NCT 04845451.

Results: Our data showed that nearly 100% of patients responded with complete relief of their cluster headaches symptoms. However, there were migraine symptoms on the opposite side after completing the original procedure, which we also addressed.

Conclusion and relevance: Systematic data collection included cluster symptoms, frequency of attack cycle, and intended pain severity. Our data collected over 270 days demonstrated long- term relief of cluster headaches symptoms. We addressed additional findings of trigeminal neuralgia by treatment of symptoms at the opposite site after resection of Neuroma using a De Novo formula/procedure. Corresponding resolution of cluster headaches by excision of a single neuroma in the property of zygomaticotemporal nerve may light future approaches to cluster headache resolution.

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