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Migraine clinical trials

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NCT ID: NCT05804396 Not yet recruiting - Migraine Clinical Trials

Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine

Start date: July 2024
Phase: N/A
Study type: Interventional

The PERL Study will evaluate the safety and efficacy of a self-administered preventive treatment for migraine headache using combined occipital and trigeminal nerve stimulation (Relivion®). This is a prospective, non-randomized, single arm, multi-center study designed to evaluate the use of Relivion® in reducing the frequency of headache days against a sham performance goal.

NCT ID: NCT05685225 Not yet recruiting - Migraine Clinical Trials

Multi-Center Study of Naltrexone-Acetaminophen in Acute Migraine, With an Exploratory Analysis of Co-occurring Anxiety

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

Naltrexone has a dual function as an opioid receptor antagonist and a Toll-Like Receptor-4 (TLR4) antagonist. While primarily approved in a 50 mg tablet for treating opioid and alcohol addiction by blocking opioid receptors, naltrexone's TLR4-blocking effect is also significant. This action reduces the levels of pro-inflammatory cytokines responsible for pain generation, primarily in the trigeminal ganglion and dorsal root ganglia. These sites play a key role in the effectiveness of naltrexone as a pain-alleviating agent. Acetaminophen is the active ingredient in Tylenol, an over-the-counter non-opioid analgesic and antipyretic agent. Both naltrexone and acetaminophen have demonstrated effectiveness in the treatment of acute migraine, physical pain, and emotional pain. However, while naltrexone has demonstrated potential in animal and human studies, confirmatory clinical trials for pain treatment in humans are still lacking. Additionally, it is important to note that around 50% of migraine patients experience co-occurring anxiety. Therefore, this study aims to assess the effectiveness of naltrexone-acetaminophen in treating migraine and co-occurring anxiety compared to each drug alone and placebo. The sponsor has conducted four clinical studies showing promising results of naltrexone-acetaminophen in treating migraine, chronic low-back pain, and emotional pain.

NCT ID: NCT05675189 Not yet recruiting - Migraine Clinical Trials

Exploring Clinical Trial Experiences of Patients With Migraine

Start date: January 2025
Phase:
Study type: Observational

Clinical study participation has historically been heavily biased toward specific demographics. This study will invite several participants to gather a wide range of information on clinical trial experiences for migraine patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of migraine. People with migraine who are invited to take part in medical research will benefit from the analysis of the data.

NCT ID: NCT05524493 Not yet recruiting - Epilepsy Clinical Trials

High-field MR Imaging in Migraine and Epilepsy

Start date: June 1, 2024
Phase:
Study type: Observational

In this project, the aim is to recruit patients with drug resistant epilepsy and those suffering from migraine. Interestingly, patients suffering from epilepsy are also more often reporting to suffer from migraine. The pathobiology is understudied, but it is believed that both etiologies results from brain networks changes. A clinical certified 7T Terra Siemens scanner will be employed to assess in all participants (including healthy controls) how the microstructure differs in disease specific areas. Patients will further be clinically assessed as well as undergo questionnaires.

NCT ID: NCT05382832 Not yet recruiting - Migraine Clinical Trials

Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine Clinical Trial

BTX/SCS/TMig
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The clinical trial is focused on the treatment of selected patients with a migraine after implantation of spinal cord stimulator (SCS) based on previous neurological examination. Patients will be randomized and divided into two groups. According to randomization patients will receive saline or botox into the epidural space. The efficacy of treatment will be compared and estimated in both groups during different SCS settings. Data will be collected in pre-set time frames.

NCT ID: NCT05334927 Not yet recruiting - Migraine Clinical Trials

China HeadAche DIsorders RegiStry

CHAIRS
Start date: August 29, 2022
Phase:
Study type: Observational [Patient Registry]

It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS), patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.

NCT ID: NCT05202171 Not yet recruiting - Migraine Clinical Trials

The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine

Start date: February 2022
Phase: N/A
Study type: Interventional

The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.

NCT ID: NCT05101837 Not yet recruiting - Migraine Clinical Trials

Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions

BE_BI_MIND_APP
Start date: October 2021
Phase: N/A
Study type: Interventional

A standardized behavioural approach based on mindfulness delivered mainly by a specific APP on android will be developed and applied for patients with chronic pain conditions, as migraine and neuropathic pain. The aim of this pilot study: The investigators propose a pilot study to enforce the application of a Home-program for patients with different pain conditions, to learn mindfulness practice, added to a regular mindfulness guided face-to-face program, by using the technology with android to receive mindfulness sessions for daily practice and to assess the feasibility and the effectiveness of behavioural approach base on mindfulness delivered with this modality.

NCT ID: NCT05046119 Not yet recruiting - Migraine Clinical Trials

Psychological and Biological Markers of Refractory Migraine

Start date: September 15, 2021
Phase:
Study type: Observational

The term "refractory" migraine describes a particularly aggressive form of the disease in which the patient does not benefit from any of the preventive therapies with the various classes of drugs available, including treatment with monoclonal antibodies directed against Calcitonin Gene Related Peptide (CGRP). Anxiety, depressive symptoms, somatization, and pain hypersensitivity are significantly more prevalent in refractory migraineurs than in non-refractory subjects who benefit from preventive therapies, suggesting that these symptoms may contribute to treatment refractoriness. Recently, in a preliminary study on the efficacy of a CGRP-targeting monoclonal antibody in Chronic Migraine (CM) patients with at least 3 failures to previous preventive treatments, the investigators showed a higher prevalence of psychological disturbances in those who did respond to the monoclonal antibody compared with the responders. These data, although preliminary, point to a more psychologically complicated picture in non-responder patients compared with responders. To date, however, no neurobiological evaluations are available to explain how psychological comorbidities may contribute to treatment refractoriness. Isolated clinical evidence and growing pre-clinical evidence suggests a role for the endocannabinoid system in migraine. Hence, the present study aims to identify psychological and biological factors associated with refractory migraine. The investigators' hypothesis is that patients presenting with psychological disorders may bear an associated dysfunction of the endocannabinoid system, which makes them more resistant to migraine preventive therapies, including monoclonal antibodies directed against CGRP.

NCT ID: NCT04984720 Not yet recruiting - Migraine Clinical Trials

Efficacy of Smartphone Based Digital Application in Improving Headache Related Parameters in Patients With Migraine

Start date: July 25, 2021
Phase: N/A
Study type: Interventional

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.