Migraine

Researchers are conducting a large-scale observational study called the Italian Migraine Registry I-GRAINE-New to better understand migraine disorders. The study focuses on adults with episodic or chronic migraine who have recently visited specialized migraine centers. It aims to analyze the prevalence and characteristics of migraine types, the impact on daily life, treatment patterns, and healthcare resource use in Italy. This study involves enrolling patients consecutively at multiple centers, where they undergo a detailed clinical and neurological examination at baseline. Follow-up data will be collected during routine clinic visits over an average of two years to observe the natural history and care pathways of migraine once patients start specialist treatment. Participants will be assessed through clinical exams and structured interviews, including validated scales like MIDAS and HIT-6, to measure disability and disease influence. The study measures the size and awareness of the migraine problem in headache centers and tracks patients treatment and healthcare use. Each patients participation lasts about 24 months from their initial visit to the migraine center.

Researchers are evaluating the analgesic effect and safety of a mixed reality MR based cognitive distraction focus relaxation therapy for patients diagnosed with chronic moderate to severe pain. This multicenter, prospective, single-blind, randomized, and parallel controlled trial aims to assess the impact of a digital chronic pain treatment system using MR technology as part of basic clinical care for chronic pain patients. Participants are assigned to one of two groups the pain key group receiving mixed reality pain treatment software with MR-based pain scenarios, or a control group exposed to the same content displayed on a 2D TV screen. The study compares these approaches to understand the role of MR technology in managing chronic pain. During the study, participants will be monitored using the Visual Analogue Scale VAS to measure pain levels over three days. Researchers will collect data on pain intensity and safety outcomes while participants follow the treatment protocols. The trial runs from October 2023 to June 2025, involving adults aged 18 to 85 years with chronic pain lasting more than three months.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing chronic migraine. This Phase 3, randomized, double-blind, placebo-controlled trial includes an extension period and aims to measure changes in the number of monthly migraine days. Participants have chronic migraine and meet specific criteria related to headache frequency and migraine history. Participants receive Xeomin or placebo injections into muscles of the head and neck at pericranial and cervical points. The study includes two Xeomin dose groups and a placebo group during the controlled period, with all groups receiving Xeomin in the extension phase. Four treatments are given approximately 12 weeks apart over a total study duration of 52 to 55 weeks. Participants take part in 14 visits over the study period, with the first, last, and four treatment visits conducted in person and the remaining eight visits by phone or video call. Researchers collect headache and migraine data from diaries and assess changes in monthly migraine days as the primary outcome. Safety is monitored by tracking treatment-related adverse events throughout the trial.

Researchers are evaluating the use of Xeomin injections to prevent episodic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections in the muscles of the head and neck to measure changes in the number of monthly migraine days. Participants have episodic migraine with or without aura, and the study aims to assess the efficacy and safety of different Xeomin doses over time. Participants receive a series of four Xeomin or placebo injections spaced about 12 weeks apart. The study includes two experimental groups receiving different Xeomin doses and a placebo group, followed by an extension period where some participants receive Xeomin. Injections are given at specific points around the head and neck. The trial lasts approximately 52 to 55 weeks, starting with a 4 to 5 week screening period. Participants attend about 14 visits, including the first and last visits and four treatment visits conducted on-site, with other visits done remotely by phone or video call. Researchers monitor changes in monthly migraine days, headache days, and medication use, as well as any treatment-related side effects throughout the study.

Researchers are investigating treatments for temporomandibular disorders TMD, which are increasingly common and affect jaw function and cause pain. This study aims to evaluate whether combining manual therapy with vagus nerve stimulation, a nerve linked to pain and jaw function, offers better relief and improved quality of life than manual therapy alone. The study involves 20 participants diagnosed with myogenic TMD, focusing on pain, jaw movement, and distress. Participants are randomly assigned to one of two groups one receiving manual therapy combined with vagus nerve stimulation and the other receiving only manual therapy. Both groups undergo four physiotherapy sessions, one per week over a month, and are trained to continue treatment exercises at home over two months. The manual therapy includes joint manipulation and soft tissue techniques for the jaw. Throughout the study, an independent evaluator will assess participants monthly using questionnaires to measure chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes are changes in health status and chronic pain after two months. This double-blind, randomized study ensures unbiased results by keeping evaluators unaware of group assignments. Participant involvement spans two months of treatment and assessments.

Migraine is a common chronic neurological condition linked to patent foramen ovale PFO, a frequent congenital heart defect in adults. This research investigates the connection between PFO and migraines, focusing on the effects of closing the PFO to reduce migraine symptoms. Previous studies suggest that closing the PFO with metal devices can reduce migraine days but may also cause new or worsened migraines due to permanent metal implants. The study aims to compare outcomes using a new biodegradable PFO occluder versus a traditional metal occluder. Participants will be randomly assigned to receive either the innovative MemoSorb4 biodegradable occluder, which dissolves over time to avoid complications of metal implants, or the conventional metal occluder device. The biodegradable occluder acts as a temporary bridge that gradually degrades while the heart tissue repairs itself. This single-blind, controlled trial will evaluate the safety and effectiveness of these two devices in patients with both PFO and migraine. During the study, participants will be monitored for migraine frequency and severity, with the main outcome being the reduction in migraine days per month measured at 12 months after the procedure. Follow-ups will include clinical evaluations and diagnostic testing to assess device performance and migraine relief. The total study duration and safety monitoring will span at least one year post-implantation to compare long-term effects of the two occluder types.

Researchers are evaluating and comparing the pain relief effects and safety of two oral migraine treatments, Rimegepant Nurtec ODT and Rizatriptan Maxalt MLT-ODT, in adults experiencing acute migraine headaches. This randomized, double-blind trial is conducted in an urban emergency department setting with adult patients diagnosed with migraine without aura, seeking to determine which medication provides better pain relief within 60 and 120 minutes. Participants receive either Rimegepant 75 mg or Rizatriptan 10 mg orally disintegrating tablets during their emergency department visit. The study involves careful monitoring of headache intensity every 30 minutes for up to 120 minutes after medication. Patients who need additional pain relief after one hour may receive rescue medication as determined by their physician. The trial includes follow-up by phone 24 hours after discharge to assess headache status and treatment satisfaction. During the study, participants will rate their pain using a validated 11-point numerical scale and describe their headache severity and functional ability using standard categorical scales. Researchers will record demographic, medical, and vital sign data, and evaluate outcomes such as pain reduction at 60 minutes, use of rescue medication, sustained headache relief for 24 hours, and patient satisfaction with treatment. The total involvement includes the emergency visit and a phone follow-up 24 hours later.

Researchers are evaluating a comprehensive digital care program called Enso for Migraine, designed to reduce migraine frequency in adults with episodic or chronic migraine. This program combines an FDA-cleared neuromodulation wearable device with personalized exercise therapy, breathing exercises, and a dedicated care team, aiming to improve migraine management through behavioral awareness and self-management tools. Participants first complete a 28-day baseline period using an electronic diary to log migraine days and compliance. Those meeting criteria then receive 12 weeks of access to the full digital care program via the Hinge Health app. The program includes acute migraine treatment with the neuromodulation device, guided exercise playlists, breathing techniques, migraine trigger tracking, and educational resources supported by a licensed physical therapist and health coach. Throughout the study, participants track migraine occurrences daily with the electronic diary. Researchers measure reductions in monthly migraine days, headache impact, work productivity, acute pain relief, and responder rates. The study lasts approximately 16 weeks, including the baseline and intervention phases, with monitoring of participant adherence and migraine-related outcomes to assess the programs clinical effectiveness.

Researchers are studying whether a home-based virtual reality VR neurofeedback program is feasible and acceptable for adolescents aged 10 to 16 years with migraine. This trial aims to see if teenagers can be successfully enrolled, randomized, and retained while completing VR sessions and study procedures, and whether the program might improve migraine-related disability and symptoms. The study compares Immersive Neurofeedback Self-Regulation Training INSeRT, which uses brain activity recorded from a wearable EEG headband, with a VR program that shows immersive imagery without neurofeedback or relaxation training. Participants complete a 4-week baseline period involving headache logs, questionnaires, and a lab EEG assessment. Then they are randomly assigned to either the INSeRT neurofeedback VR or the comparison VR imagery program. Both groups do VR sessions at home three times a week, each lasting about 8 minutes, over 4 weeks. Questionnaires and a repeat EEG assessment are done after treatment and again approximately 3 months later. During the study, participants log headaches, complete questionnaires, and undergo EEG brain activity tests to measure changes. Researchers track recruitment, randomization, treatment adherence, retention, and symptom changes. Outcomes include the number and duration of VR sessions completed, treatment credibility, cybersickness symptoms, and migraine disability scores. Participants are followed for about 3 months after treatment to assess longer-term effects and safety.

Researchers are conducting a first-in-human, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of TT5 given at different doses in healthy volunteers and surgical patients. This phase 1 trial includes both single and multiple ascending dose parts and involves healthy and surgical participants aged 18 to 55 years. The study aims to explore TT5s effects, including psychological responses and potential fluid biomarkers. The study consists of three parts Part A tests single ascending intravenous doses of TT5 in healthy participants across up to five dose levels Part B evaluates multiple ascending doses over seven days in healthy participants with up to three dose levels and Part C administers intravenous doses on the same day to surgical patients in up to three dose levels. Both TT5 and placebo vehicle are given intravenously, and dosing schedules vary according to the study part. Participants will be monitored for adverse events, vital signs, physical exams, laboratory tests, and psychological responses using tools like the Bond and Lader Visual Analog Scale. Pharmacokinetic measurements will include plasma and urine analysis over specified days. Safety and tolerability will be assessed through day 8 for single doses and day 14 for multiple doses. The total study duration varies by cohort, with close follow-up during and after dosing to evaluate TT5s effects and safety.