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Cluster Headache clinical trials

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NCT ID: NCT01616511 Completed - Clinical trials for Chronic Cluster Headache

Pathway CH-1 Long-Term Follow-Up

Start date: June 2012
Phase: N/A
Study type: Observational

The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.

NCT ID: NCT01589588 Completed - Clinical trials for Cluster Headache Attacks

Administration of Oxygen to Cluster Headache Patients

Start date: April 2012
Phase: N/A
Study type: Interventional

This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.

NCT ID: NCT01447641 Completed - Cluster Headache Clinical Trials

Sleep, Circadian Rhythms and Cluster Headache

Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of this study is to assess both the sleep and circadian (24-hourly biological rhythms) physiology of people with cluster headache. For sufferers with the episodic form of the disorder this will involve observation at two separate time points, once when experiencing attacks (in-bout) and once when attack free (out-of-bout). The study will include measurement of basic rest-activity patterns, sleep timing and timing of individual attacks, as well as a more detailed study recording sleep and circadian rhythms under clinical conditions over consecutive nights. Studying the differences in these processes in single individuals when they are both experiencing and free from attacks might provide insight into the brain mechanisms involved in triggering the bouts of attacks and individual attacks themselves. An improved understanding of this area may help design improved treatment options in future.

NCT ID: NCT01406860 Terminated - Clinical trials for Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches

Start date: July 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.

NCT ID: NCT01395264 Terminated - Migraine Clinical Trials

Saccadometry in Primary Headache Syndromes

Start date: August 2011
Phase: N/A
Study type: Observational

Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs > €27 billion per annum across Europe. Despite its prevalence and impact, migraine pathophysiology is poorly understood. A wider understanding of the functional changes in this disorder would be beneficial to both diagnosis and treatment. Saccades are the rapid eye movements we make when moving the eyes to a new object in our visual field. Reaction time studies have been used to investigate Huntington's disease and Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements). Even at rest we make approximately three saccades per second, so a lot of data can quickly be gathered with non-invasive testing. We hope to understand more of the underlying mechanisms of migraine by studying reaction time in migraine patients. Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed significantly different saccadic patterns to non-migraineurs. This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study in a group of migraineurs, and secondly to explore the specificity of these findings in migraine by also studying patients with another primary headache syndrome, namely cluster headache. Migraine is known to be a dynamic disorder, with previous studies showing longitudinal changes in the migraine brain. To explore this further we hope to record longitudinally (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal changes in saccadic reaction time. Because of the portability of the equipment this could be done in the subjects own home if they preferred.

NCT ID: NCT01359631 Completed - Clinical trials for Chronic Cluster Headache

Cephalic Vascular Recording Upon SPG Stimulation

Start date: June 2011
Phase: N/A
Study type: Observational

Hypothesis: Stimulation of the SPG at high frequencies (50-200Hz) is believed to cause a physiological parasympathetic block which decreases VMCA oxyHb concentration and cephalic vessel diameter. Stimulation of the SPG at low frequencies (1-60 Hz)is believed to cause a physiological parasympathetic upregulation which increases VMCA, oxyHb concentration and cephalic vessel diameter.

NCT ID: NCT01341548 Not yet recruiting - Clinical trials for Episodic Cluster Headache

Civamide Nasal Solution for Cluster Headache

ECH
Start date: November 2023
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01298921 Terminated - Cluster Headache Clinical Trials

A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache

Start date: January 2011
Phase: Phase 1
Study type: Interventional

Cluster headache is a disorder marked by frequent attacks of short-lasting, severe, unilateral head pain with associated autonomic symptoms. It is the most severe head pain syndrome known. Currently, the two most common treatments for cluster headaches are inhaled oxygen and injectable sumatriptan. These treatments do not work for all cluster headache patients, and patients who smoke may eventually develop contraindication to triptans. New treatment options are needed. An alternative method of oxygen delivery (as opposed to continuous flow) uses a demand valve that is controlled by respiration rate, allowing increased oxygen flow in response to increased demand. This system may be more efficacious at stopping a cluster headache attack than the currently prescribed oxygen delivery system. This study will compare the effectiveness of oxygen delivered via demand valve versus continuous high flow oxygen via non-rebreather face mask in the acute treatment of a cluster headache attack. All patients will treat one cluster headache with each of the 2 treatment methods.

NCT ID: NCT01255813 Completed - Clinical trials for Chronic Cluster Headache

Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

Start date: December 2010
Phase: N/A
Study type: Interventional

The purpose of the proposed clinical study is to evaluate the use of an implanted Neurostimulator to provide Sphenopalatine Ganglion (SPG) stimulation for the management of the pain associated with cluster headaches.

NCT ID: NCT01151631 Completed - Clinical trials for Chronic Cluster Headache

Occipital Nerve Stimulation in Medically Intractable Chronic Cluster Headache

ICON
Start date: October 2010
Phase: Phase 3
Study type: Interventional

Cluster headache (CH) is a primary headache disorder characterized by recurrent short-lasting attacks (15 to 180 minutes) of excruciating unilateral periorbital pain accompanied by ipsilateral cranial autonomic signs. The 1-year prevalence of CH is about 0.1 %, the male: female ratio is 3:1. The majority of patients have cluster periods of weeks to months with frequent attacks which are alternated with symptom-free periods of months to several years; the episodic from of CH. In about 10% of patients the CH is chronic (CCH) in which either no remission occurs within 1 year or the remissions last less than 1 month. At least 10 % of CCH patients are refractory to medical treatment or cannot tolerate the treatments. Recent pilot studies suggest that occipital nerve stimulation (ONS) in medically intractable CCH (MICCH) might offer an effective alternative to medical treatment. There are no randomised clinical trials and a placebo effect cannot be excluded. Long term tolerability is known from other indications. Here the investigators propose a prospective, randomised, double blind, parallel group multi-centre international clinical study to compare the reduction in attack frequency from baseline of occipital nerve stimulation (ONS) in patients with MICCH between two different stimulation conditions: high (100%) and low (30%) stimulation. Following implantation there will first be a run-in phase of 10 days of 10% stimulation intensity, followed by a stepwise monthly increase up to either 30% or 100%. Patients will be assessed monthly by a blinded assessor. The primary outcome measure is the mean number of attacks over the last 4 weeks of the double blind 6 month treatment period in the 100% versus the 30% treatment group. Hereafter, in an open extension phase of 6 months, all patients will receive 100% stimulation or the stimulation considered optimal by the patient. Secondary outcome measures include the rate of responders (≥ 50% reduction in attack frequency during the last 4 weeks of each treatment period), patient's satisfaction, medication use, quality of life, mean pain intensity, economic evaluation and whether patients would recommend the treatment to another patient. The investigators will also investigate whether predictive factors can be identified for efficacy.