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 person's 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 medication's 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 the use of nerve block injections in the pterygopalatine fossa (PPF) to manage headaches in people who have survived aneurysmal subarachnoid hemorrhage (SAH). This phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial compares active PPF nerve blocks containing ropivacaine and dexamethasone to placebo saline injections. The study also monitors blood flow in brain arteries using transcranial Doppler during the treatment periods to assess safety and effects. Participants are randomly assigned to one of three groups: one receiving active PPF nerve blocks in both stages, one receiving placebo injections followed by active blocks, and one receiving placebo injections in both stages. Each active injection contains 20mg ropivacaine plus 4mg dexamethasone, while placebo injections consist of saline. The treatment phase spans 48 hours with two injection stages, followed by assessments for safety and tolerability. During the study, participants provide pain scale scores and undergo monitoring of intracranial artery flow velocities with transcranial Doppler. Researchers evaluate pain relief within 24 hours after each injection and monitor safety up to 48 hours from the first injection. Participants must be available for the study duration and comply with procedures, which include neurological assessments and tracking of headache symptoms. This trial seeks to better understand the potential of PPF nerve blocks as an opioid-sparing treatment for acute headache after SAH.

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 1/2 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 studying patients aged 12 years and older who have primary headaches or medication-overuse headache (MOH). The study collects detailed information including biomarkers, imaging features, cognition tests, genetic data, social and demographic factors, medical history, treatments used, and outcomes related to headache disorders. This large registry plans long-term follow-up to better understand headache-related diseases and their progression. The study includes several groups based on headache type: medication overuse headache or new daily persistent headache, chronic migraine, episodic migraine, and other primary headaches. Some participants receive treatments prescribed in routine clinical practice, such as Yangxue Qingnao Granules or biological drugs like eptinezumab and erenumab, with treatment details decided by their doctors and patients. Follow-up visits occur frequently in the first 18 to 24 months and then annually thereafter. Participants will be followed up regularly at specific time points including 1, 2, 3, 6, 9, 12, 18, and 24 months, then annually for up to 10 years. Researchers will perform assessments such as MRI scans, cognitive tests like MoCA and MMSE, headache diaries, and various questionnaires on disability, anxiety, depression, sleep quality, and fatigue. Long-term monitoring aims to capture headache days, genetic analysis, brain imaging changes, and quality of life outcomes over a decade.

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.