Clinical Research Directory

MMA Embolization for Refractory Chronic Migraine

This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine.

Videonystagmography and Vestibular Migraine

In the study, the investigators would like to examine whether there is a difference between patients with vestibular migraine, patients with episodic or chronic migraine and healthy subjects in the examination of videonystagmography, which has been used for many years to differentiate and diagnose vertigo disorders. Accordingly, videonystagmography could also be discussed as an important diagnostic instrument for the diagnosis of the still young disease vestibular migraine.

EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization

This single-site, open-label pilot study evaluates the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy targeting meningeal arterial contributors to migraine. Adults aged 18-60 with refractory migraine despite prior preventive therapies are eligible. The study assesses migraine outcomes over 12 months using patient-reported headache frequency, pain intensity, acute medication use, migraine-related disability (MIDAS), and quality-of-life measures (MSQ v2.1).

(Italian Migraine Registry, I-GRAINE-NEW)

Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic "evolutionary" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments. When patients are admitted to the center is therefore the time when their history in terms of disease evolution and healthcare costs is most effectively collected, but also when it is assumed that the treatment strategy offered to the patient will have a greater impact. For this reason, it was decided to conduct a large-scale retrospective and prospective observational study in order to draw a detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started. Design A multicenter, observational, retrospective and prospective cohort study, aimed at obtaining a more detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.6,000 of the incident patients (defined as those who had their first visit during the 6 months preceding enrollment in the registry), will be invited to take part in a follow-up and expanded data collection study. Patients will be consecutively enrolled by specialists at each individual site.. Eligible patients who agree to take part in the study by signing an informed consent form will be assessed clinically and through a direct interview with a structured questionnaire organized in several ad hoc sections. Objectives: The aim of the study is: analyze episodic and chronic migraine in Italy from an epidemiological point of view, especially in terms of prevalence of the two forms of migraine and their endophenotypes in different population subgroups; 2. characterize the demographic distribution and clinical characteristics of patients (including the definition of endophenotypes); 3. measure the influence of the disease on the patient's daily activity, in terms of disability (assessed using the validated MIDAS and HIT-6 scales); 4. study the clinical and care pathway (patient journey) and identify the preferred care pathways based on the characteristics of the patients and the migraine subtype; 5. evaluate the prescribed pharmacological treatments, medical visits and diagnostic procedures performed (ascertaining the degree of adherence to current guidelines); 6. analyze the use of health resources by migraine patients, with particular attention to their impact on the SNS. Visits and Treatments: Baseline Visit: Patients enrolled in the study will undergo a thorough clinical and neurological examination. Follow-up Visits: Clinical data will continue to be collected over time, at each scheduled clinic visit based on the needs of clinical practice. Study Population: Adult patients of both sexes with episodic or chronic migraine who have recently attended a specialized migraine center in the I-GRAINE-NEW registry. Estimated Study Duration: The duration of each patient's participation in the study is 24 months from the date of the initial visit to the participating migraine site

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.

This study aims to verify the efficacy/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Transcranial direct current stimulation is used in the field of Physiotherapy and Rehabilitation, with results that have proven to be effective for treating patients suffering from symptoms like migraines, headaches, chronic pain, fibromyalgia, or chronic neuropathic pain and insomnia. As you can see, in the case of patients with Long Covid, we find several of these symptoms, so it is suggested that if transcranial direct current therapy (TDCS) gives such good results in relieving these symptoms, why couldn't it give such good results and help just as much in patients with Long Covid, since many of the symptoms are the same, even if the origin or cause is different.

Greater Occipital Nerve Block for Migraine With Medication Overuse Headache

Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH). Treatment of MOH is challenging and the primary therapeutic approach is reducing painkillers which helps decrease the number of headache days. As a part of the detoxification process to discontinue acute medications, bridging therapy is often needed to reduce withdrawal headache. Currently, there are data supporting the use of greater occipital nerve block as a preventive treatment in chronic migraine, but no placebo-controlled trial has evaluated the efficacy of greater occipital nerve block in MOH. Therefore, this research aims to demonstrate the efficacy of greater occipital nerve block in detoxification of migraine patients with MOH. Patients will be recruited from Headache Clinic at 3 centers in Thailand from February 2026 to January 2028. After recruitment, patients will be randomized into 2 groups at a 1:1 ratio using a block of four, namely group A and B. A 5-mL syringe of 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg) will be prepared for each patient in group while a 5-mL syringe of 4 mL normal saline will be prepared for each patient in group B. Monthly headache days, duration, severity, acute medication type and number of usage days and relative headache status according to a 5-point Likert scale will be investigated at the 2 weeks, 1st, 2nd and 3rd month, MIDAS at the end of 3rd month.

Using Virtual Reality to Teach Mindfulness to People With Migraine

The aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.

Migraine Manager (R01)

The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.

EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine

EMBRACE-OBS is the first phase of the EMBRACE research program. This single-site observational registry accesses and analyzes patient-reported outcome data already collected through routine clinical care from adults with migraine who have undergone or plan to undergo middle meningeal artery (MMA) embolization. The study describes changes in headache frequency, headache severity, medication use, migraine-related disability, quality of life, and reported adverse events over time without influencing clinical care.

Migraine Attack Pain Phase Prediction Study

The study of the ability to predict pain in a migraine attack, through premonitory symptoms and through an ambulatory monitoring device through real-time recording of hemodynamic variables, is one of the strategic lines of research of the unit. of Headaches at the Hospital de La Princesa since 2013 together with the Complutense and Polytechnic University of Madrid. Their results have been reflected in various publications (Pagán J, et al. Sensors 2015; Gago-Veiga AB, et al. J Pain Res 2018) and have promoted the creation of several invention patents.

Mind Body Balance for Pediatric Migraine

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.

Responding With Evidence and Access for Childhood Headaches

This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.

Prevalence of Primary Headache in Multiple Sclerosis Patients

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that can cause a wide range of neurological symptoms. Headache is increasingly recognized as a common yet frequently overlooked symptom that significantly impairs quality of life and daily functioning in people with MS. While international reports suggest a high frequency of primary headache disorders, primarily migraine and tension-type headache, in individuals with MS, data evaluating headache patterns among Egyptian MS patients remain limited. The purpose of this observational study is to determine the prevalence and specific types of primary headache disorders among adults with MS attending Assiut University Hospitals, classified according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). The study also aims to evaluate how headache disorders relate to patient demographics, MS disease duration and phenotype, neurological disability, MRI lesion characteristics, disease-modifying therapies, cognitive function, anxiety, and depression. Participants will complete a single-visit cross-sectional evaluation consisting of: * A detailed clinical interview and neurological examination covering medical history, MS course, and headache characteristics. * Neurological disability scoring using the Expanded Disability Status Scale (EDSS). * Review of brain and spinal cord magnetic resonance imaging (MRI) scans. * Standardized assessments for cognitive performance (Montreal Cognitive Assessment \[MoCA\]), anxiety (Hamilton Anxiety Rating Scale \[HAM-A\]), and depression (Hamilton Depression Rating Scale \[HAM-D\]). No experimental medications or procedural interventions are administered as part of this study.

Tai Chi for the Prophylaxis of Episodic Migraine: the Efficacy Examination and Mechanism Exploration

The proposed study aims to examine the clinical efficacy of 24-week Tai Chi training in the prophylaxis of episodic migraine comparing with standard prophylactic medication in Hong Kong Chinese women, and to explore the mechanism of Tai Chi's intervention effect by examining the associations of changes in migraine features with neurovascular and neuroinflammation variations.

Multi-Segmental Spinal Manual Therapy in Women With Episodic Migraine

The purpose of this study is to evaluate the clinical effects of multi-segmental spinal manual therapy on pain intensity, central sensitization (CS), and sensorimotor control in women diagnosed with episodic migraine (EM). Participants receive 10 sessions of a comprehensive manual therapy intervention targeting the cervical, thoracic, lumbar, and sacral regions over a 2-week period. Clinical outcomes-including headache pain intensity, sensorimotor dysfunction, headache-related disability, and cutaneous allodynia-are evaluated at baseline, immediately after the 2-week treatment, and at a 1-month follow-up. This study aims to investigate whether addressing multiple spinal segments with manual therapy improves clinical symptoms, spinal motor control, and central pain processing in female individuals with EM.

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine

This is a clinical trial to assess the efficacy of botox treatment of the sphenopalatine ganglion as an add-on treatment in drug resistant migraine. An injection targeting the ganglion is made possible by an image-guided device developed specifically for this purpose (MultiGuide) Study participants will be randomized to either placebo or botox after a 4 week run-in period. First, one injection will be given towards both the right and the left ganglion. After that there will be a follow-up of 12 weeks for efficacy and safety evaluation. The main efficacy measure is change in number of moderate to severe headache days before and after injection.

Headache Ear Auditory Dizziness Sinus (HEADS) Registry

The Headache, Ear, Auditory, Dizziness, Sinus (HEADS) Registry is a study over time of individuals living in the United States who experience sinus, vestibular, auditory, and headache symptoms. Through an online portal, participants are asked questions about their symptoms, how they have affected their lives, and how effectively they have managed them. This information is then used to better understand these symptoms and to improve patient diagnosis and treatment. Some potential research benefits of the HEADS Registry include: * Improving healthcare professionals' understanding of the causes of specific head and neck symptoms. * Reducing delays in diagnosis and the use of inappropriate tests, medications, and surgeries. * Finding the most effective treatments for sinus, vestibular, and auditory disorders. * Providing participants the opportunity to be contacted for additional important research related to sinus, vestibular, and auditory disorders. All U.S. residents over the age of majority who experience sinus, vestibular, and auditory symptoms, with or without migraine, are eligible to participate. Enrollment is voluntary, confidential, and free of charge.

Preventive Role of Melatonin and Propranolol Administration in Pediatric Migraine

This randomized controlled trial evaluated whether adding melatonin to propranolol provided better prevention of migraine in children than propranolol alone. The study included 60 children aged 5-15 years with migraine, diagnosed according to the International Classification of Headache Disorders criteria, who attended the Pediatric Outpatient Department of Nishtar Hospital, Multan. Participants were randomly assigned in equal numbers to receive either melatonin 3 mg at bedtime plus propranolol 1 mg/kg/day in two divided doses, or propranolol 1 mg/kg/day alone, for three months. Migraine attacks, pain severity, attack duration, migraine-related disability, use of pain-relieving medicines, treatment adherence, and adverse effects were recorded at baseline and during follow-up visits at one, two, and three months. Parents or caregivers maintained a daily headache and medication diary throughout the treatment period. Blood pressure and pulse rate were also monitored because propranolol may cause low blood pressure or a slow heart rate.

Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial

Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use

To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.

MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine

The purpose of the study is to develop, evaluate, and optimize "MigraineManager", the first web-based comprehensive self-management tool for adolescents with migraine, their parents, and clinicians.

Determining the Utility of a Behavioral Intervention in Chronic Migraine

This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.

Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas as Well as Subnuclei of the Spinal Trigeminal Nucleus

In previous studies clustering of the three branches of the trigeminal nerve in brainstem were shown, cerebellum and periaqueductal gray. To further evaluate higher cortical structures, which were not covered by our previous field of view (FOV) and to further investigate the identified 'subnuclei' of the spinal trigeminal nucleus, here the aim is to scan the whole brain as well as the brainstem and the upper spinal cord during trigeminal nociceptive as well as non-nociceptive electrical stimulation of all three branches of the trigeminal nerve (and the arm as a somatic control site) during acquisition of BOLD-fMRI in humans.