View clinical trials related to Cluster Headache.
Filter by:This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction. Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute attack and preventive treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters.
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of cluster headache. The data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.
The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised. Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor…) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity…). As it is a feasibility study, only 5 patients will be included.
This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH). It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period. Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH. Additional objectives: - To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH. - To explore the exposure-response relationship of 25μg LSD in cCH. - To assess the effect of treatment with 25μg LSD on hypothalamic functional connectivity in patients with cCH, using resting state functional magnetic resonance imaging (rsMRI). - To explore cost-effectiveness of treatment with LSD in cCH. - To evaluate the efficacy of LSD on health-related quality of life.
Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer [18F]F13640.
The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.
The purpose of this study is to test the effects of sodium oxybate on headache response (frequency), sleep quality and quality of life in the prophylactic treatment of patients with chronic and episodic cluster headache. Oral sodium oxybate, 3-9g per night, starting with 3g in two nightly dosages of 1.5g and increased by steps of 1.5g every second or third night until treatment Response will be evaluated in an interventional, placebo-controlled, double-blind, randomised, parallel group, multicentre study. Primary outcome is reduction of nocturnal pain frequency Secondary outcomes are improvement of sleep quality at a subjective level as assessed by diary and standardized scales (PSQI, FOSQ), duration of pain free episodes, general clinical outcome (global evaluation), clinical global impression (CGI-S, CGI-I, CGI-E), quality of life (SF 36) and daytime sleepiness (Epworth Sleepiness Score).
The purpose of this study is to evaluate the safety and efficacy of intranasally administered civamide nasal solution in the prevention of cluster headaches during an episodic cluster headache period.