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Migraine clinical trials

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NCT ID: NCT04930887 Recruiting - Migraine Clinical Trials

Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain

Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).

NCT ID: NCT04925414 Recruiting - Migraine Clinical Trials

Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)

MiOx
Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits. Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine. However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc. In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient. In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

NCT ID: NCT04921384 Recruiting - Migraine Clinical Trials

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

Sunrise
Start date: May 29, 2021
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.

NCT ID: NCT04904458 Recruiting - Migraine Clinical Trials

Enfacement Illusion and Chronic Migraine Pain

Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The concept of body image can be described as "the intentional content of consciousness comprising perceptions, attitudes and beliefs relating to one's body". Over the years, there has been a growing interest in this topic, highlighting that body image can be distorted in people suffering from pain conditions, especially in the case of chronic pain. One way of modulating the perception of pain through the perception of body image is through the use of interventions based on visual feedback. In this regard, some studies have highlighted the possibility of reducing the perception of pain in healthy and clinical populations with the use of "illusions" of one's own body created through immersive virtual reality. For example, through the use of synchronous visual-tactile multisensory stimulation on one's own face / body and on that of others (fake body), is possible to induce illusions of self-recognition in other fake bodies. In the case of the face, this type of illusion of belonging of other faces is commonly known as the "enfacement illusion", through which is possible to change or modulate the self-representation, with important implications for all those subjects who have distorted body representations, such as patients suffering from chronic pain. The main goal of the present protocol is to evaluate the effects of an experimental treatment based on enfacement illusion on the perception of pain (VAS scale) with respect to a control condition (pleasant virtual environment exposure). The secondary objective is to study any correlations between pain and body image, personal, clinical and psychological intrapersonal variables. One-hundred patients with chronic headache will be randomly assigned to the two conditions: experimental group (based on the "enfacement illusion") and control group (exposed to a pleasant virtual environment). Both conditions include an immersive virtual reality treatment of 3 sessions of 15 minutes each, during one week.

NCT ID: NCT04842474 Recruiting - Migraine Clinical Trials

Effectiveness of Gaze Stability Exercises on Balance and Activities of Daily Living Among Patients Suffering Vertigo With Vestibular Neuritis in Saudi Arabia

Start date: February 7, 2021
Phase: N/A
Study type: Interventional

Gaze stability exercise is a medical procedure for persons with unilateral vestibular disturbances such as vestibular neuritis or persons who have had tumors of their 8th nerve. They are a crucial part of the vestibular dysfunction rehabilitation protocols in health centers. These activities which involve turning one's eyes at different angles while having their eyes focused on an optotype are aimed at helping improve the vestibular ocular reflex (VOR), visual acuity during head movements and also reducing vertigo and dizziness. Study aim: This review will be establishing the effectiveness of applying gaze stability with balance exercises procedure among participants who are suffering vertigo due to vestibular neuritis. Methods: Twenty volunteers between the age of 25-59 years old, diagnosed, and confirmed to be suffering from vestibular neuritis and vertigo will be used in this study. Gaze stability exercises will be performed while patients are in a seated position. Each exercise will last for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance exercises will be performed in a standing position including both static and dynamic training with or without closing eyes. The following outcome measures for each participant will be assessed pre-and post-treatment after completing four weeks of intervention. They include; Arabic version of Activities-Specific Balance Confidence Scale (A-ABC scale), Arabic version of Dizziness Handicap Inventory (A-DHI), Berg Balance Scale (BBS), and Katz Index of Independence in Activities of Daily Living (Katz ADL). The findings will then be subjected to statistical methods and data analysis using the SPSS toolkit. In this study we hypothesis that practicing gaze stability and balance exercises will have a positive influence on balance and activities of daily living among vestibular neuritis patients.

NCT ID: NCT04803513 Recruiting - Migraine Clinical Trials

Observational Study on the Efficacy, Safety, and Tolerability of GAlcanezumab in Real Life Migraine Patients in ITaly

GARLIT
Start date: November 1, 2019
Phase:
Study type: Observational

Objective: To determine in real life the efficacy, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic (CM) migraine. Design: This prospective observational cohort study was conducted between November 2019 and January 2021. Participants: Consecutive adult HFEM and CM patients clinically prescribed galcanezumab were enrolled. Setting: Multicenter study in 13 Italian headache centers. Exposure: Galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg. Main Outcome(s) and Measure(s): The primary end-point was the change in monthly migraine days (MMDs) in HFEM patients and monthly headache days (MHDs) in CM ones after six months of therapy (V6) compared to baseline. Secondary end-points included variation in Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6, and MIDAS scores. We assessed 50%, 75%, and 100% responder rates (RR), the conversion rate from CM to episodic migraine (EM), and the Medication Overuse condition to the non-overuser.

NCT ID: NCT04726592 Recruiting - Migraine Clinical Trials

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

Start date: July 8, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room

NCT ID: NCT04715685 Recruiting - Migraine Clinical Trials

Mind Body Balance for Pediatric Migraine

Start date: March 9, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04702971 Recruiting - Migraine Clinical Trials

Decoding Pain Sensitivity in Migraine With Multimodal Brainstem-based Neurosignature

Start date: February 26, 2021
Phase: Phase 4
Study type: Interventional

Migraine is a highly prevalent and disabling neurological disease, which has a tremendous impact on sufferers, healthcare systems, and the economy. According to the 2016 WHO report, migraine is the second leading cause of years lived with disability, greater than all other neurological diseases combined. Yet, the treatment in migraine is far from optimum; the sufferers often abuse painkillers and complicated with medication overuse headache. Migraine is characterized by the hypersensitivity of the sensory system, potentially attributed to dysfunctional pain modulatory networks located in the deep brain structures, particularly the brainstem. However, the current understanding of these deeply seated, dysregulated pain modulatory circuits in migraine is limited due to technological constraints. Besides, studies with an in-depth analysis of the clinical manifestations (i.e., deep phenotyping) are lacking, and there is no corresponding animal model readily available for translational research. In this project, the investigators propose a multimodal approach to address these issues by applying the technologies and platforms developed by our team to explore the correlation between pain sensitivity and dysregulated connectivities from brainstem to other brain regions. In this four-year project, the investigators will recruit 400 migraine patients and 200 healthy subjects. The investigators aim at decomposing the key brainstem mechanisms underlying dysmodulated pain sensitivity in migraine from 5 comprehensive perspectives: (1) clinical deep phenotyping, (2) high-resolution brainstem structural MRI and functional connectivity analysis, (3) innovative brainstem EEG signal detecting technique, (4) multimodal data fusion platform with neural network analysis, and (5) ultrahigh-resolution brainstem-based connectomes, intravital manipulations and recording, and connectome-sequencing in animal models. Moreover, the investigators will collaborate with Taiwan Semiconductor Research Institute to develop a wearable high-density EEG equipment, integrated with a System-on-Chip capable of edge-computing the signal using algorithms derived from our brainstem decoding platform. The ultimate goal is to build a real-time brainstem decoding system for clinical application.

NCT ID: NCT04696458 Recruiting - Migraine Clinical Trials

Effects of a Multispecies Probiotic on Migraine

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The prevalence of migraine is higher in female patients with various intestinal diseases. An explanation could be that migraine is caused by a leaky gut, defined by increased intestinal permeability that permits particles to pass through the gastrointestinal wall. Probiotics, may be able to improve intestinal barrier function. OBJECTIVE: To test whether probiotics, as adjucnt therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.