Active clinical trials for "Migraine Disorders"

Medication Overuse Headache (MOH) is a disabling condition that affects the 2% of migraine population. Medication overuse (MO) makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse, but it is also confirmed that patients have to be carefully followed after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. Clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, the regular clinical practice adopted for patients with CM-MO has changed in the last weeks: patients cannot come to the hospital for the withdrawal iv therapy and for regular follow up as the reduced mobility due to the emergency in particular in the Lombardia region, but all over Italy. So the investigators propose a pilot study to enforce the application of a Home-program for the withdrawal procedure for patients and the use of technology like smartphone and video calls so that patients can continue to be followed in their therapeutic process by using behavioral support and mindfulness practice. Patients will perform the withdrawal program at home, by oral administration of therapies, with specific instructions and education. Also the information for behavioral approach and mindfulness practice will be given, to use every day at home. Daily standardized mindfulness sessions of 12 minutes on their smartphone will be combined with weekly video-call to evaluate the clinical condition and to encourage the use strategies for pain management. Face-to-face visits at the follow up every three months will be scheduled. This modality will allow the patients to continue their therapeutic process and to be regularly followed during the one year after withdrawal.

This is a randomized study for the prevention and acute treatment of migraine using open label nVNS and standard of care versus standard of care. .

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.

Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).

Migraine is a condition thought to be related to cortical hyperexcitability. Repetitive transcranial magnetic stimulation (rTMS) can modulate the cortical excitability by means of long-term potentiation or long-term depression. This study will will test the safety and efficacy of rTMS in the treatment of patients with Migraine.

: Headaches are a common complaint presenting to the emergency department (ED), accounting for 1-2% of all ED visits, with migraines as the second most common primary headache syndrome. Patients that ultimately present to the ED have failed outpatient therapy and exhibit severe and persistent symptoms. Treatment options have been traditionally with a parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as standard therapy in the treatment of migrainne headache in the ED. Today, there are a number of nonopioid treatment options, but not without their own individual concerns. Ergotamine and dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used as an anti-emetic agent, has been widely studied for use with acute migraines. Its side effects include drowsiness and dystonic reactions. Compazine has been successfully used to treat migraine headaches for the past several decades, and has been accepted as standard treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects, dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have no addictive properties, few side effects, quick onset, be highly effective and have a low rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of neuropetides, which have been implicated in migraine. Native somatostatin is an unstable compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches associated with growth hormone secreting tumor has been established. 4 Five somatostatin receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The distribution of sst2 within the central nervous system strongly suggests that this particular somatostatin receptor has a role in cranial nociception, being highly expressed in the trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double blind study comparing octreotide to placebo in treating migraine. They found there to be a significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo (76% vs 25%, p<0.02). They noted that 47% of those in the octreotide group had complete relief compared to no patients in the placebo group. They went on to note that those patients in the octreotide group had earlier relief of symptoms and no side effects. The only minor adverse event related to the administration of octreotide was a local reaction in 3 patients (18%). In a study performed recently in Netherlands, no clinically relevant changes in vital signs, routine chemistry, and urinalysis were observed with octreotide use. Electrocardiogram analyses showed no newly occurring or worsening of known cardiac abnormalities 2 and 24 h after injection with octreotide. 5 Levy et. al also compared octreotide to placebo in a double blinded study but found no difference. This was a poorly designed study, in that the patients treated themselves at home with an injection of either placebo or octreotide for 2 episodes of headache and recorded their level of pain relief at 2 hours. Matharu et. al also performed a double blind study comparing octreotide to placebo, but looking at cluster headaches rather than migraines. They found there to be a significant improvement with the use of octreotide over placebo (52% vs 36%). At Darnall Army Community Hospital the cost of 100 mcg Octreotide and10 mg Compazine, is $10.46, $2.02-8.00, respectively.

Migraine headache is one of the disabling conditions that may be associated with decreased quality of life, anxiety and depression. Currently, therapeutic approach to migraine is mostly based on prophylactic and acute phase medication therapy. Some investigators consider migraine a biopsychosocial condition which means that psychological therapies, such as cognitive-behavioral therapy and relaxation, may be efficient in controlling the disease. According to previous studies, cognitive therapies, including cognitive-behavioral therapy, have been efficient in decreasing frequency and severity of migraine, however, there are some challenges in applying these kind of interventions: the expenses; presence of multiple commodities that may lead to confusion and bewilderment for both therapist and patient; small number of trained psychologists for this intervention. The trans-diagnostic approach, however, can facilitate some challenges with the previous method. Since it is not focused on a single condition, trained psychologists with this approach can apply it for a wide range of conditions, including migraine. Also, the trans-diagnostic approach leads to lower chances of confusion and bewilderment for therapist and patients. The trans-diagnostic approach focuses on therapeutic modules instead of constant similar therapeutic models. The five cores of trans-diagnostic approach are emotional awareness, cognitive flexibility, recognizing and preventing emotion avoidance and maladaptive emotion driven behaviors, awareness and tolerance of emotion-related physical conditions, and introceptive and situation-based emotion-focused exposure. This method was first designed to replace cognitive-behavioral therapy for emotional disorders, due to its feasibility and applicability. The trans-diagnostic approach has been investigated by several researchers so far, however, most of those researches evaluate the efficacy of the technique on psychiatric disorders. It has also been investigated for treatment of headaches in adolescents. But no other study on other clinical problems or migraine has been conducted. Considering the high rates of comorbid anxiety and depressive symptoms in migrainous patients and the feasibility and efficacy of trans-diagnostic cognitive-behavioral therapy in other conditions, we aimed to evaluate its efficacy on controlling headache and related symptoms among migrainous patients.

This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants with chronic migraine.

Chronic migraine (CM) is a very disabling disorder with grave socioeconomic consequences. Pharmacological approaches can affect mechanisms of pain production, while rehabilitation such as Transcutaneous Electrical Nerve Stimulation and Manual Therapy may reduce the neuromuscular contributing factors. The main aim of the study is to evaluate the effects of cervical and thoracic manipulative techniques combined with OnabotulinumtoxinA prophylaxis on headache frequency in patients with Chronic Migraine (CM). The second aim is to evaluate the training effects on the intensity of headache attacks, analgesic consumption, cervical range of motion, TrPs sensitivity and disability. The hypothesis is that the manipulative treatment would alleviate CM symptoms and, in turn, decrease the analgesic consumption.

The purpose of the study is assessment of the safety and efficacy of the De-Novo therapy in the treatment of craniofacial neuralgia and migraine headaches.This is an open-label study of simultaneous administration of combination of dexamethasone, lidocaine, and thiamine into the trigeminal nerve branches as well as greater and lesser occipital nerve bilaterally in one session. Patients who meet the exclusion and inclusion criteria are eligible for trial if they have experienced chronic migraine and craniofacial pain not responding to other prior therapies.