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NCT ID: NCT02777359 Recruiting - Clinical trials for Patent Foramen Ovale

Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The foramen ovale, a kind of physiologic channel in the interatrial septum in the heart at embryonic stage, is closed normally at 5-7 months after birth. When it is not closed, it is referred to as the patent foramen ovale (PFO), which is found in approximately 1/4 of general population. It was shown in the studies in recent years that the risks of cryptogenic stroke, migraine, peripheral arterial embolism and decompression sickness in the patients with PFO were several times higher than those in healthy people. Therefore, PFO, previously considered a condition without the necessity of treatment, causes the attention of many experts and scholars around the world. Migraine with or without aura is defined as one of the most disabling chronic diseases, since according to WHO, the disability adjusted life year caused by migraine was second only to that by non-fatal stroke in 2005. In recent years, an increasing number of researches suggested that migraine is closely related to the right-to-left shunt (RLS) in the heart. And PFO is clinically considered as the most common cause of RLS. The closure treatment for PFO-induced migraine has been gradually applied in several hospitals in China. The relationship of PFO with migraine, however, was not evaluated systematically based on specific standards, unfortunately leading to non-inclusion of many high-risk patients with PFO in the evaluation. The following aspects are to be fully recognized: the selecting and screening procedures for the high-risk population with PFO-induced migraine; the indications and standards of closure treatment for PFO in the patients with PFO-induced migraine; and the possibility that the made-in-China occluders substitute for those imported in the prevention from migraine. Furthermore, there is still a lack of prospective, multi-center, randomized and controlled studies in this subject, and standard or normal screening and treatment procedures have not yet been established in China. From this point, the investigators developed the Chinese people-specific procedures and standards of diagnosis of PFO-induced migraine in this study, based on current standards and methods of diagnosis, treatment and prevention of PFO-induced migraine in foreign countries. And the investigators prospectively adopted continuous inclusion of the high-risk patients with PFO-induced migraine, who were randomly divided into the closure treatment (transcatheter closure of PFO) group and the medication (drugs administered alone) group at the ratio of 1:1., in order to evaluate if the interventional treatment is better than the medication alone in these patients, to assess the efficacy and safety of the made-in-China occluders in the interventional treatment and prevention of PFO-induced migraine, and to identify the incidence of PFO in the patients with migraine in China and develop the Chinese people-specific screening protocols of PFO-induced migraine.

NCT ID: NCT02753933 Recruiting - Chronic Headache Clinical Trials

Direct Access to MRI and Neurology Referrals for the Management of Patients With Chronic Headache.

Start date: April 2016
Phase: N/A
Study type: Observational

This study aims to evaluate whether direct access from General Practitioners (GPs) to Magnetic Resonance Imaging (MRI) for patients with chronic headache decreases overall NHS costs and increases patient satisfaction compared to clinical practice with referral to Neurology Services.

NCT ID: NCT02681211 Recruiting - Migraine Headache Clinical Trials

Auricular Acupuncture vs SOC in Migraine HA

MigAcu
Start date: February 2016
Phase: N/A
Study type: Interventional

Patients with migraine headache will be offered the opportunity to participate in this randomized study evaluating auricular acupuncture versus standard treatment for migraine headaches for patients in the pediatric emergency department (ED).

NCT ID: NCT02549300 Recruiting - Clinical trials for Headache Disorders, Primary

The Effects of Connective Tissue Massage and Lifestyle Modifications in Adolescents Tension Type Headache

Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of connective tissue massage and lifestyle modifications in adolescents tension type headache, pain severity, pain duration, pain frequency and quality of life and pressure pain threshold rates. The patients will be accepted to study according to 'The International Classification of Headache Disorders-III' criteria. Including criteria are; being between 10-19 ages adolescents, suffering from tension type headache at least for 6 months, pain severity between 4-7 on visual analog scale. Excluding criteria are; current pregnancy, having any history of cancer, traffic accident, head trauma and any kind of neurological disorder. Patients will be divided into two groups randomly. The investigators plan to receive 30 patients to the study. 15 of them will be in control group, 15 in study group. Control group will just receive some advices including life style modifications, like using right glasses, not smoking, true posture habits and regular and quality sleep habits. In addition to life style modifications, the other group will be treated with connective tissue massage. Connective tissue massage will be applied on basic part, lower thoracic, scapular, inter scapular and neck regions, 5 times a week, totally 20 sessions in a month. Each session lasts approximately 20-30 minutes. Patients detailed medical history and demographic data will be recorded. Pain severity, duration, frequency, analgesic usage, connective tissue evaluation of back, range of motion of neck, pressure pain threshold for pain sensitization measurements and quality of life will be evaluated before treatment and after 4 weeks of treatment.

NCT ID: NCT02302027 Recruiting - Chronic Headache Clinical Trials

Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache

O214
Start date: December 2014
Phase: N/A
Study type: Interventional

Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal . The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use. The aim of this study is 1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator 2. use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period. It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks. Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake). Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months Effective : 30 patients

NCT ID: NCT02081482 Recruiting - Clinical trials for Refractory Chronic Cluster Headache

Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation

MET-ONS
Start date: March 2014
Phase: N/A
Study type: Interventional

The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network. The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic headache.

NCT ID: NCT01943929 Recruiting - Headache Clinical Trials

Correlation Between Headaches and Septum and Nasal Mucosa Contact

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

Headache is the most common complaint to neurologists. In the 80´s and 90's few papers, with limited number of patients, have proposed the association between nasal septum contact and headache. The International Classification of Headaches Disorders proposed specific diagnostic criteria for this entity. With the major use of CT scans, the contact between nasal mucosa and septum is daily observed in many patients without complaint of headache. The purpose of this study is to determine if there is any correlation between nasal and septum mucosa contact and the prevalence of headache. The investigators hypothesized that no correlation will be found using CT scans in a large series of patients.

NCT ID: NCT01917474 Recruiting - Headache Clinical Trials

Effects of Changes in Dietary Intake and Headache's Attacks

Start date: July 2013
Phase: N/A
Study type: Interventional

Headache is a frequently disabling disorder, which occurs in about 30% of the adult population, particularly in overweight/obese women. Aim of the study is to modify the nutritional habits of the patients and to evaluate the effects of a low lipid intake vs. a normal lipid diet on the incidence and severity of migraine crises. Moreover vascular reactivity will be evaluated in a randomly selected subgroup of patients. This randomized, cross-over intervention trial will be performed in about 150 patients, affected by migraine. Adherence to the diet, particularly regarding energy intake, percent of energy from lipids, carbohydrates and proteins will be carefully assessed at baseline and during the 2 intervention periods

NCT ID: NCT01842763 Recruiting - Clinical trials for Refractory Chronic Headache Disorders

French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

NGO
Start date: March 2013
Phase:
Study type: Observational

The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation. Every team using this neuromodulation approach in France is likely to participate in the network. Fifty patients a year are expected. They will be informed about data which are collected and why they are collected. The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner. These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data. This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.

NCT ID: NCT01806155 Recruiting - Headache Clinical Trials

Prevalence of Post-craniotomy Headache in Siriraj Hospital

Start date: March 2013
Phase: N/A
Study type: Observational

Headache after major craniotomy may be a problem in taking care of the patients. The investigators want to identify the incidence of headache after major craniotomy and also the risk factors.