View clinical trials related to Migraine Disorders.
Filter by:To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, atenolol, topiramate, valproic acid/sodium valproate, levetiracetam, gabapentin, lamotrigine, pre-gabaline, flunarizine, amitriptyline, nortriptyline, clomipramine, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment or that changed the preventive treatment less than 3 months from the study start, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort, clobazam, macrolides, verapamil, fluoxetine, amiodarone and tacrolimus. Patients on vitamin K anticoagulant medicines, as warfarin. Randomization using a computacional system will stratify participants in each group by gender (F/M), age (25-34/35-44/45-54/55-65yo), headache days presented in the baseline month (5-10/11-15/16-20/21-25/26-30), overuse medication (yes or no). After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum daily dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit). The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample. Clinical data will be registered on a personalized headache diary developed to this study using MyCap, from RedCap System, as an APP for daily entries using smartphones, androids or IOS system. The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary endpoints, the proposal of which is to publish the data regardless of the results obtained.
Migraine is a common headache disorder and affects 1 in 5 adults during their lifetime. It is a disorder which leads to significantly impaired quality of life, absence from work, loss of productivity in workplace and reduced vitality in social functioning. One of the important cornerstones in the management of migraine is the maintenance of a good headache diary. A headache diary enables the physician to understand the headache characteristics as well to establish the triggers causing the precipitation of episodes. The other important measure to ensure good outcomes is compliance to medications in those who have been prescribed prophylaxis. Migraine prophylaxis is by pills that have to be taken everyday at fixed time to ensure best outcomes. However, it is known that patients with migraine often are not adherent to prophylactic medications. A meta-analysis of 33 studies found that observational studies (n = 14) showed adherence ranging from 41% to 95% at 2 months after initiation of medication and 21% to 80% at 6 months. Pooled rates of persistence derived from 19 RCTs on propranolol, amitriptyline, and topiramate showed adherence rates of 77%, 55%, and 57%, respectively, at 16-26 weeks of initiation. The real world adherence is expected to be lower than that in the ideal settings of randomized trials. Regular pill reminders issued through smartphone based applications can improve medication adherence and thus improve headache outcomes. Though smartphone based migraine tracker digital applications are available, they mostly are aimed at capturing headache characteristics. The efficacy of providing pill reminders along with patient educational materials and community blog to enable migraineurs share their experiences with each other has not been studied in controlled trials. It is known that patients who are well informed about their chronic diseases such as migraine often have better outcomes. Busy clinicians often resort to providing pamphlets regarding the disease, triggers, acute pain relief medications, prophylactic therapy etc. However, it is yet to be studied if a digital application with all these inbuilt features, which are easily accessible at the finger tips would lead to better information uptake and improved compliance and self management. This RCT would try to assess this gap in knowledge.
This study collects data from migraine and cluster headache patients during a three-month study. Contextual data (e.g. location or smartphone usage) and physiological variables will be used to assist machine learning algorithms in making predictions on activity, stress and sleep in patients with migraine or cluster headache.
In this study the investigators hypothesize, that Osteopathic Manipulative Therapy (OMT) will reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents with treatment over 12 week time frame. The investigators aim to decrease severity and disability of migraine by utilizing Osteopathic Manipulative Therapy. This would ultimately reduce the utilization of office or emergency department visits, decrease the large economic burden the United States faces for migraine patients as well as improve quality of life for the 3 million chronic migraine patients.
Headache is a neurological condition that is very common all over the world and is observed at some time in life in more than 90% of society. Migraine headache, known for thousands of years, is one of the oldest diseases of humanity. The word 'hemicrania', meaning 'half of a head', is used due to unilateral pain. Approaches to treating migraine include medication, relaxation, biofeedback, living a regular life, adequate sleep, exercise, and stress management. Neck pain is especially common in migraine patients. Exercise, manual practices, electrop novelties are used to reduce musculoskeletal problems, thus reducing the effects of migraine. Myofascial relaxation techniques, which are included in the manipulative techniques in the literature, are relaxation methods performed on myofascial trigger points.Osteopathic manual therapy (OMT) , which has recently entered the literature, 19. osteopathy, developed by Andrew Taylor STILL at the end of the century, is a treatment system characterized by focusing on integrity and using it by hand to heal diseases.The study of cranial OMM kraniyum first anatomical and physiological mechanisms for the prevention and treatment of disease as a whole is concerned with the relationship of the body, including diagnostic and therapeutic methods.It is used in the treatment of somatic dysfunction of the head and other body parts. An important component of cranial Omm is the primary respiratory mechanism, which occurs as movement of the head bones, sacrum, dural membranes, central nervous system and cerebrospinal fluid. The primary respiratory mechanism is synchronous with the cranial rhythmic impulse, a 2-phase rhythmic cycle that represents a dynamic metabolic exchange with each stage of the body. This cycle is indicated as loops between 7 and 14 per minute.Fascial mobilization therapy increases energy use in segments implemented by mechanical changes.Accordingly, it helps to reduce the spasm of these layers extending fascially, to dissolve adhesions, and to increase the range of motion of the joint. H0: Osteopathic Manipulative Therapy has no effect on migraine symptoms. H1: Osteopathic Manipulative Therapy has an effect on migraine symptoms. H2: myofascial relaxation techniques have no effect on migraine symptoms. H3: methods of Osteopathic Manipulative Therapy have an effect on migraine symptoms. H4: myofascial relaxation techniques and osteopathic manipulative treatment methods have no superiority over each other. H5: myofascial relaxation techniques and osteopathic manipulative treatment methods have superiority over each other.
Chronic Migraine (CM) and High Frequency Episodic Migraine (HFEM) without Aura affect adolescents' lives in terms of reduced health, reduced ability to perform daily chores and reduced quality of life. The use of pharmacological prophylaxis in these patients warrants caution, whereas the use of behavioral treatments is gaining support in literature. The main aim of MINDKIDS trial is to test the effect of a seven weekly group sessions of guided mindfulness-based meditation program on 12-month headache frequency reduction, medications intake, disability, anxiety, depression, catastrophizing, and caregivers' burden. This is a single-arm study. All patients will participate to seven weekly guided sessions (60 minutes each) of guided mindfulness meditation, which is aimed to teach and make direct practice with skills intended to enhance sustained, non-judgmental present moment awareness. The intervention's main topics are: posture education; breath use and control; guided body scan; work with sounds; tension release; guided imagery; decentralization of thoughts. Each session is conducted by a neurologist and a psychologist expert in mindfulness practice. During the sessions, patients are asked to close their eyes and focus their attention on the breathing so that they can concentrate on the present moment and on all the sensations. Patients were educated to promote a healthy lifestyle: regular physical activity, avoiding skipping meals, hydration, maintain a regular sleep/wake pattern at least 7-8 hours per night.
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
Study Objectives: To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and 60 mg once daily for the prevention of chronic migraine (CM). To prospectively test for superiority of atogepant 30 mg BID and 60 mg once daily versus placebo for the prevention of CM.
This is an observational, longitudinal cohort pilot study measuring physiological signals through wearable sensors combined with machine learning algorithms to detect behaviour, stress and headaches in patients with migraine and cluster headache.
A multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of sumatriptan naproxen sodium succinate tablets in the treatment of acute migraine attacks.