Cluster Headache Clinical Trial
Official title:
Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues
Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary
symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial
sweating. The headache is believed to be the most intense of all headaches and among many is
totally disabling and of great personal and social consequences. For a small group of
patients with episodic and most chronic form, drug therapy has little effect. For them,
surgery can be a solution.
Neuroradiology has found evidence of a possible original activation of cluster headache from
the portion of the brain called hypothalamus. Furthermore, an activation of the
parasympathetic nervous system through the sphenopalatine ganglion, which may also explain
some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of
Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve
signals being blocked. The duration of such a blockade is believed to be 3-9 months.
The purpose of the present study is to develop and evaluate a new surgical procedure with
injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the
symptoms of refractory cluster headache with a minimal invasive procedure.
The main objective of the project is to determine the safety of BTA injection in the area of
the sphenopalatine ganglion of refractory cluster headache and detect the adverse events.
Secondary objectives are to identify the changes of headache attacks by the method used.
n/a
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