View clinical trials related to Cluster Headache.
Filter by:The investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache.
This study investigates molecular and physical biomarkers of headaches in order to better understand mechanisms of these diseases. There are 3 main parts: 1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of calcitonin gene related peptide - the hypothesis is that this will be different in headache subjects compared to controls (and if so might be used to predict how these patients will respond to certain medications that modulate calcitonin gene-related peptide). Subjects will be given capsaicin as a cream applied to the forehead or the inner nostril, or a hot sauce that is ingested. 2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow down the amount of eye watering. Cluster headache patients respond very powerfully to oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents there is data that it works on the parasympathetic / lacrimal gland system. This study translates rodent data into humans in a non-invasive way to confirm the mechanism of this very effective treatment. 3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but intense headache that may cause similar biomarker release as other headache disorders. This may be a useful human model for other headache disorders.
Sleep study in episodic cluster headache patients.
Cluster headache is also called suicide headache due to excruciating nocturnal attacks. There are few treatment options available. Inhalation of oxygen has shown to abort the attacks. Continuous positive airway pressure (CPAP) is a machine used during sleep to treat respiratory failure. Automatic CPAP machines adjust the air pressure through the night to keep the upper airways patent. Single reports have shown a high prevalence of obstructive sleep apnea in people suffering from cluster headache, and positive effects of CPAP treatment, but no randomized controlled trial has been conducted so far. If proven effective CPAP would make an affordable treatment option for many patients within the existing healthcare system.
The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.
Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but carbohydrate restriction. It is followed by millions of people around the word as a life-style, but in the last years was proposed as a treatment for the epilepsy, by its capacity to induce the state of ketosis. Since Authors observed that ketosis could be also useful in migraine, and migraine shares some pathophysiological features with cluster headache, The aim of the study is to test the efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.
This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies [ADAs]), and biomarker analyses. Participants will return to the investigational center for a follow-up visit to evaluate ADAs, fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant medications) approximately 7.5 months after the last dose of IMP.
Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of the most severe pains known to man, having a large impact on the sufferer's quality of life. A parasympathetic dysfunction in CH has been suggested. The sphenopalatine ganglion has been a target for treatment of primary headache disorders for more than a century but there are several anatomic and physiologic studies that suggest that another cranial parasympathetic ganglion, the otic ganglion (OG), might be also relevant in CH. In this study OG will be blocked with botulinum toxin type A in a pilot study in 10 patients with chronic cluster headache. Recruitment of patients will be solely in Norway. There is no data available to determine the correct dosage of botulinum toxin. A similar neural structure that has been blocked with botulinum toxin in humans is the sphenopalatine ganglion. The investigators injected 10 patients suffering from intractable chronic cluster headache with botulinum toxin in the sphenopalatine ganglion. 5 patients were given 25 IU and 5 patients were given 50 IU. Even though the number of treated patients is low, there did not appear to be differences in the adverse events profile between those who received 25 Iu and those who received 50 IU. The investigators also previously injected 25 IU botulinum toxin towards the sphenopalatine ganglion bilaterally (i.e. 25 IU in each side) in 10 patients suffering from intractable chronic migraine. Doses of up to 25 IU have been injected in structures adjacent to the otic ganglion, for instance in dystonia towards the lateral pterygoid muscle. Thus it was decided for this study on injection towards the otic ganglion, to explore the safety of 12.5 and 25 IU of botulinum toxin.
There is a significant debate whether local infiltration techniques may be a method to treat complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of evidence regarding efficacy of this treatment especially in long term follow up. Similarly, indication and management are under debate. Aim of this trial is to analyse pain scores during first treatment with anaesthesiological infiltration series.
Cluster headache is one of the most painful headaches, characterized by recurring episodes of unilateral, periorbital pain, which is accompanied by autonomic symptoms that seem to be of both sympathetic and parasympathetic origin. The pathophysiology behind the condition is largely unknown, but increasing evidence indicate that the hypothalamus plays a pivotal role. The headache attacks come in clusters or bouts (hence the name) which last up to three months, after which the headache disappears for at least one month. 10-15% have chronic cluster headache. During attacks, the patients have cranial sympathetic hypoactivity and parasympathetic hyperactivity, whereas they have cranial parasympathetic hypoactivity during remission phase. There is an emerging hypothesis that headache attacks are elicited in a state of autonomic hypoarousability, which is also supported by the fact that most cluster attacks occur during the night, when the patients are sleeping. The aim in this project is to study the intercept between the sleep-wake cycle, autonomic tone and the occurrence of headache attacks, by using actigraphy, heart-rate variability and pupillometry. All these methods are well validated, and frequently used in studies on sleep and autonomic function. The study design is that of a case-control model where 15 cluster headache patients will undergo pupillometry, before wearing the actigraph and heart-rate variability-monitor for two weeks, once in cluster bout and once in remission phase. The actigraphy will register nocturnal movement and sleep quality, and headache attacks will be registered by pressing a button on the actigraph. The pupillometry measures pupillary constriction and dilation in response to light, a reflex that is controlled by the autonomic nervous system. The heart-rate variability monitors fluctuations in the heart rate which reflects the sympathovagal balance of cardiac control. All participants will fill out the Pittsburgh Sleep Quality Index before and after registration. In addition, 15 healthy controls will undergo one session of the same examinations. The results of the study will give valuable insight to the pathophysiology of a condition that is very painful and has great impact on the patients' quality of life, and also add knowledge to the relation between headache, sleep and the autonomic nervous system.