Cluster Headache

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.

Migraine is a neurological disorder that causes significant disability and affects sensory processing, musculoskeletal function, and psychosocial health. Researchers are evaluating how combining supervised aerobic exercise with pain neuroscience education compares to general physical activity recommendations in women aged 18 to 48 diagnosed with migraine. The study aims to better understand the effects on sensory perception, musculoskeletal changes, and migraine-related symptoms. Participants will be randomly assigned to one of two groups. The intervention group will attend a single pain neuroscience education session followed by supervised aerobic exercise on a treadmill three times a week for 16 weeks, with exercise intensity tailored to each persons heart rate reserve. The control group will receive guidance to increase physical activity independently at home, aiming for 10,000 steps daily or at least 150 minutes weekly, without supervision or structured education during the same 16-week period. Participants will undergo assessments before and after the 16-week intervention, including migraine-related disability, sensory sensitivity, self-reported symptoms, quality of life, psychosocial factors, and musculoskeletal function using questionnaires and physical tests. A follow-up at six months will collect self-reported outcomes. Researchers will monitor adherence, and the findings may help develop accessible, low-risk non-drug treatment options for migraine.

Researchers are evaluating a behavioral intervention to reduce chronic headaches in children aged 8 to 15 years. The study aims to assess how using virtual reality combined with biofeedback can help children learn relaxation techniques like deep breathing, improve their confidence in managing pain, and reduce headache frequency and intensity. The study also compares this approach to similar relaxation training without virtual reality and to a control group receiving only psychoeducation. Participants are randomly assigned to one of three groups relaxation training with virtual reality and biofeedback, relaxation training with biofeedback alone, or a control group receiving psychoeducation through video modules at home. The interventions last for 8 weeks with sessions including psychoeducation, relaxation training, and homework exercises to reinforce skills. Throughout the study, researchers will monitor headache frequency and intensity, self-efficacy, pain coping strategies, and satisfaction with the intervention at the start, immediately after the 8-week program, and two months later for intervention groups. Additional assessments include daily diaries during treatment, pain perceptions, functional disability, and questionnaires about the virtual reality experience. The total participation involves these assessments and follow-ups over several months.

Researchers are evaluating the effectiveness of corticosteroids for treating acute post-concussion headaches. This study aims to determine if corticosteroids can reduce headache frequency and intensity more than the current standard care. It also explores whether corticosteroid use can lessen other symptoms like vestibular issues, helping patients return sooner to school, work, or sports. This novel pilot project focuses on patients with post-concussion headaches, a condition lacking established treatment guidelines despite its high prevalence and associated disabling symptoms such as depression and sleep problems. Participants will receive a Methylprednisolone dose pack, a corticosteroid medication tapered over seven days with a specific daily dosing schedule starting at 24 mg on day one and decreasing to zero by day seven. The treatment is taken orally following detailed instructions. The study does not mention a placebo or comparator group, focusing instead on evaluating this medications impact on post-concussion headaches during the treatment period. During the study, participants will be monitored over 12 weeks to assess changes in headache symptoms, overall post-concussion symptoms, quality of life through health questionnaires, and other medication use with pain tracking diaries. The primary outcome is the change in headaches one week after treatment starts. Secondary outcomes include symptom scores and quality of life measures at 12 weeks. Participants adherence to the medication regimen and symptom changes will be carefully observed to understand corticosteroids role in managing post-concussion headaches.

Researchers are evaluating bilateral pterygopalatine fossa PPF injections using a combination of 20mg ropivacaine and 4mg dexamethasone compared to saline placebo for treating headaches in survivors of aneurysmal subarachnoid hemorrhage SAH. This phase II, multicenter, randomized, double-blinded, placebo-controlled trial uses a sequential parallel comparison design to assess the interventions effects while monitoring intracranial arterial flow using transcranial Doppler TCD during the intervention period. Participants are randomly assigned to one of three groups Group 1 receives active PPF nerve blocks in both stages, Group 2 receives a placebo injection in the first stage followed by an active PPF nerve block in the second stage, and Group 3 receives placebo injections in both stages. The active nerve block consists of 20mg ropivacaine plus 4mg dexamethasone, while placebo injections consist of normal saline. The trial involves two stages of double-blinded treatment over 48 hours. During the study, participants are monitored for efficacy, safety, and tolerability outcomes within 24 to 48 hours after each PPF injection. Researchers assess headache relief and measure intracranial arterial flow velocities using TCD. Participants must be able to communicate their pain scores using an 11-point scale. The study lasts until the primary completion date with ongoing monitoring of treatment responses and adverse effects.

Cluster headache is a condition causing repeated intense one-sided headaches, which can be episodic or chronic. The study evaluates whether a precise injection of botulinum toxin type A targeting the sphenopalatine ganglion SPG, a nerve area involved in pain attacks, can reduce the frequency of attacks in patients with chronic cluster headache. This is a randomized, placebo-controlled, triple-blinded Phase 3 trial to explore this treatment approach further based on earlier promising phase 12 results. Participants receive either a single injection of botulinum toxin type A or a placebo injection, both targeted at the SPG on the headache side of the face, using the Multiguide navigation system for precise delivery. The botulinum toxin dose is 25 Allergan units in 0.5 ml sodium chloride, compared with 0.5 ml sodium chloride alone for the placebo group. The study compares changes in headache attack frequency and intensity during weeks 5 to 8 and weeks 9 to 12 after injection. Throughout the study, participants are monitored for changes in the number and intensity of cluster headache attacks, as well as any adverse events. The primary outcome is the difference in average weekly attacks between weeks 5 and 8 post-injection compared to baseline. Secondary outcomes include safety assessments and responses in predefined subgroups. The study lasts through 12 weeks post-injection, with careful adherence to current headache medications and contraception requirements for women of childbearing potential.

Researchers are collecting data from patients aged 4 to 99 years who experience various headache types, vertigo, and chronic pain conditions like fibromyalgia. This observational study aims to investigate the biological markers, imaging features, heart-lung right-to-left shunts, genetic traits, treatments, and outcomes related to these headache and vertigo disorders. Long-term follow-up is planned to better understand these conditions over time. Participants include groups with migraine including vestibular migraine, other primary headache disorders such as tension-type and cluster headaches, other vertigo disorders, secondary headache disorders, and a control group without headache or vertigo. The study gathers real-world treatment data and evaluates multiple clinical and biological characteristics to support comprehensive analysis. During the study, participants will undergo various assessments including biomarker collection, imaging, genetic analysis, and detailed clinical evaluations. Researchers will track outcomes such as migraine and headache days, vertigo attacks, headache severity, medication use, patient quality of life, and safety measures over periods ranging from six months to as long as 30 years. Data accuracy and participant privacy are closely maintained throughout the study.

Researchers are conducting a large observational study called the China HeadAche Disorders Registry CHAIRS to better understand primary headaches and medication-overuse headaches MOH in patients aged 12 years and older. The study aims to collect detailed information including biomarkers, brain imaging, cognitive and genetic data, as well as social, demographic, medical, and treatment-related data. Long-term follow-up is planned to observe outcomes related to headache disorders over many years. Participants include those with various types of primary headaches such as migraine, tension-type headache, new daily persistent headache, and MOH. The study includes behavioral follow-up visits at multiple time points monthly for the first 18 months, then at 24 months, and annually thereafter. Some participants are observed during routine clinical use of treatments like Yangxue Qingnao Granules, Erenumab, and Eptinezumab, with treatment decisions made by their physicians and outcomes tracked over 12 weeks or longer. Throughout the study, participants undergo periodic assessments including MRI scans, cognitive tests like the Montreal Cognitive Assessment MoCA and Mini-Mental State Exam MMSE, and questionnaires evaluating headache impact, anxiety, depression, quality of life, sleep quality, and fatigue. Data on headache frequency, severity, medication use, and biological samples are collected. Follow-up can extend up to 10 years, allowing researchers to monitor long-term changes and outcomes related to headache disorders and treatments.

Researchers are evaluating the effectiveness of an endoscopically guided injection of Exparel Bupivacaine for treating craniofacial pain conditions such as migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglion neuralgia, and paroxysmal hemicrania. This Phase 2 prospective, randomized, double-blinded, placebo-controlled, and crossover study aims to determine whether injecting Exparel into the lateral nasal wall can improve pain and functional outcomes in patients who respond to topical Lidocaine during ENT endoscopy. Participants receive either an injection of Exparel Bupivacaine Liposome, a non-opioid pain reliever, or a saline placebo through an endoscopic procedure targeting the ipsilateral pterygopalatine fossa. The study administers a single dose of 3cc bilaterally. The trial involves a crossover design where patients receive both treatments in different periods to compare effects. During the study, pain scores and associated symptoms will be monitored from baseline through day 21 to assess changes. Participants will attend clinic visits at the Stanford Pain & ENT Clinic, where their pain and functional outcomes will be evaluated. The total participation period includes assessments up to 21 days after treatment, with safety and symptom monitoring throughout. The study excludes pregnant women, those allergic to bupivacaine, and individuals unable to consent or participate fully.

Researchers are evaluating the combined use of repetitive transcranial magnetic stimulation rTMS and telehealth-based therapy to help manage headaches related to mild traumatic brain injury mTBI. The study involves veterans and active military personnel who experience persistent headaches after mTBI and aims to compare active rTMS with telehealth therapy against placebo treatments in reducing headache intensity and related symptoms. Participants will be randomly assigned to one of four groups combining active or sham rTMS with either telehealth headache management therapy or headache education control. The treatment includes 10 neuronavigation-guided rTMS sessions over two weeks, alongside weekly telehealth sessions for headache therapy or education from weeks 3 to 10, plus three additional monthly booster telehealth sessions. The study spans about 6 to 7 months with multiple phases including pre-treatment assessments, induction treatment, and post-treatment assessments with maintenance treatments. During the 19 in-person visits and 11 telehealth sessions, participants undergo MRI scans and assessments of headaches, neurobehavioral symptoms, depression, post-concussion symptoms, and quality of life. Researchers measure changes in headache intensity, frequency, and interference along with other symptom scales at multiple follow-up visits up to 20 weeks. This comprehensive evaluation helps monitor symptom changes and treatment effects throughout the study period.