Extrait

Background and study aims Cluster headaches are a type of headache which involves excruciating attacks of pain on one side of the head. They can affect people of any age, but tend to be more common in men and people over the age of 20. Attacks can be described as stabbing and of the most severe intensity “like a knife penetrating behind the eye”. Cluster headaches can be difficult to treat with 15-20% of patients not responding to drug treatment. The severity of pain and the frequency of attacks seriously degrade patients’ quality of life, justifying the consideration of other, more drastic therapies. Trans-nasal endoscopic vidian neurectomy is a surgical technique is a surgical technique which involves severing or removing the vidian nerve (a nerve in the head). The aim of this study is to find out whether this procedure is an effective treatment for long-term (chronic) cluster headaches. Who can participate? Adults who have been suffering from daily cluster headaches for three years. What does the study involve? All participants undergo a trans-nasal endoscopic vidian neurectomy while under general anesthesia (put to sleep). After this procedure, most patients can leave the hospital at the same day and without other discomforts except a feeling of fullness in the nose. At the start of the study and then one week and one, three and six months after the surgery, patients are interviewed and complete a questionnaire to find out if their symptoms have improved. What are the possible benefits and risks of participating? Participants nay benefit from an improvement to their cluster headache symtpoms. There is a risk of developing dry eyes, a dry nose or numbness in the palate (roof of the mouth). Where is the study run from? Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Taiwan) When is the study starting and how long is it expected to run for? August 2011 to December 2016 Who is funding the study? Investigator initiated and funded (Taiwan) Who is the main contact? Dr Shao-Cheng Liu [email protected]

Critère d'inclusion

• Chronic cluster headache

Liens

• isrctn