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NCT07348783
Brief Summary: Migraine and/or Cluster Headache: Study Overview \*\*Background:\*\* Migraine and cluster headache are two primary headache disorders that significantly impact quality of life and functionality in those affected. According to the WHO's recurring burden of disease reports, migraine is among the neurological conditions responsible for the highest number of years lost due to illness. The headaches associated with migraine and cluster headache range from moderate to severe and cause great suffering. Available treatments do not work for everyone and are often associated with adverse side effects. Physical activity has been shown in several studies to have a positive effect on headache. Given the high prevalence of mental health issues, stress, and sleep problems within this patient group, relaxation and low-intensity exercise such as yoga-based movements (YB) could potentially help individuals improve sleep and well-being, while also providing some preventive effect on headaches. \*\*Hypothesis:\*\* Individuals with severe migraine or cluster headache have a strong need for new treatment options. Alternative therapies such as yoga-based exercises, when combined with standard medical treatment as per clinical guidelines, may positively impact: Headache symptoms, Sleep quality and Overall life quality * Purpose and Goals:\*\* This randomized controlled study aims to evaluate the effect of a web-based yoga (YB) or live face to face (FTF) intervention in individuals suffering of primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related changes in headache frequency, intensity, and duration associated with primary headache conditions, with a focus headache frequency. A secondary objective is to analyze quality of life, sleep quality, mental health as depression and anxiety. The RCT will also measure objective sleep and biomarkers. We are now summarizing the effects after a pilot study. * Relevance for the Patient Group:\*\* The core objective of the project is to determine whether yoga-based exercises can serve as a complementary treatment to enhance quality of life and health in patients with severe primary headache. To ensure equal healthcare access, this intervention will be delivered in digital format and/or FTF to optimize availability and expand care for individuals with primary headache disorders. These efforts aim to improve life quality and well-being in a vulnerable patient population. Headache conditions often affect individuals in their most productive years, and many live with symptoms for decades. Both work and private life are frequently disrupted, resulting in sick leave and social isolation. Close relatives are also affected, as those suffering from headaches require more recovery time to cope with daily life. With this proposed project, we aim to use physical yoga, rooted in holistic traditional medicine, to help individuals with severe primary headache achieve better physical and mental health-particularly improved sleep quality, which in turn enhances overall life quality.
NCT07370142
Purpose of the Study: This study aims to evaluate the clinical effectiveness and long-term outcomes of "Sphenopalatine Ganglion (SPG) Pulsed Radiofrequency (PRF)" treatment in patients with chronic headaches and facial pain. The SPG is a major neural junction for craniofacial pain signaling. PRF is a safe, minimally invasive technique that modulates pain transmission without causing thermal damage to the nerve tissue. Methodology: The study will include 55 volunteer patients at the Ankara Bilkent City Hospital Algology Clinic who are unresponsive to medical treatments. Patients will undergo the standard "fluoroscopy-guided infrazygomatic approach." Pain intensity (VAS), quality of life, patient satisfaction, and changes in analgesic consumption will be recorded at baseline and during follow-up visits at 1 week, 1 month, 3 months, and 6 months post-procedure using various clinical parameters. Expected Benefits and Risks: The research intends to provide evidence regarding the 6-month long-term impact of this intervention on pain scores and patient well-being. Since the study follows routine clinical practices, it poses no additional risks to participants and aims to optimize future treatment strategies.
NCT06841627
Chronic headaches are associated with changes in brain structure and function that may be associated with increased suffering and disability. Understanding how Osteopathic Manipulative Therapy (OMT) affects these changes would reveal new insight into how the brain processes pain and returns to normal function. Also, demonstrating these changes would provide evidence regarding how OMT causes a reduction in pain and disability, supporting the recommendation for OMT as a primary treatment option for headaches.
NCT02910323
The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is a prospective, multicenter, observational research network for subjects with Cluster Headache and/or Trigeminal Neuralgia.
NCT03511846
This study investigates molecular and physical biomarkers of headaches in order to better understand mechanisms of these diseases. There are 3 main parts: 1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of calcitonin gene related peptide - the hypothesis is that this will be different in headache subjects compared to controls (and if so might be used to predict how these patients will respond to certain medications that modulate calcitonin gene-related peptide). Subjects will be given capsaicin as a cream applied to the forehead or the inner nostril, or a hot sauce that is ingested. 2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow down the amount of eye watering. Cluster headache patients respond very powerfully to oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents there is data that it works on the parasympathetic / lacrimal gland system. This study translates rodent data into humans in a non-invasive way to confirm the mechanism of this very effective treatment. 3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but intense headache that may cause similar biomarker release as other headache disorders. This may be a useful human model for other headache disorders.
NCT07418723
This project was an empirical single-case experimental design (SCED) study conducted as part of a DClinPsy doctoral thesis completed by one of the researchers. The study used a brief and highly personalised psychological intervention for adolescents experiencing headaches. The aim was to understand how participants' real-time data could guide the personalised intervention provided to adolescents, including the development of skills to cope with headaches. The study began with an initial assessment of adolescents' (n = 6-8) headache experiences. Following this, the researchers formulated an individualised diagram for each participant to identify central problem areas or problematic responses relevant to their headaches. Based on these formulations, the team delivered a brief personalised intervention focused on developing adaptive psychological skills and coping responses. The intervention consisted of 4-5 weekly, 30-minute, one-to-one online sessions, targeting headache-related areas of concern. These sessions drew from established Cognitive Behavioural Therapy (CBT) and Acceptance and Commitment Therapy (ACT) interventions, both of which have previously been shown to reduce headache-related disability and improve functioning. During data collection, adolescents were prompted to complete brief online questionnaires on their smartphones. The questionnaires were personalised to each participant and measured specific psychological processes that had been identified as target areas during the assessment and formulation stages. This personalised data collection approach was then used to analyse individual-level changes and to explore how these changes facilitated progress in areas identified as important to each adolescent (e.g., school involvement or extracurricular activities). The study also examined whether overall headache-related disability decreased and whether daily functioning improved following the completion of the intervention.
NCT06277063
This study is a single-center, single-arm study. All subjects will receive the same treatment. Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters.
NCT04939922
In the Chinese Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned.
NCT06816849
The aim of this study is to investigate the role of hydration and fluid intake in children and adolescents with primary headaches.
NCT04570475
This study intends to investigate the use of high-dose Vitamin D3 plus a multivitamin in the prevention of cluster headache attacks. Participants can be enrolled anywhere in the United States that has access to one of our participating labs (for blood work - anticipated to be available in most of the USA). The study may include: * Screening: Participants may be interviewed, examined, fill out surveys, and get blood testing * Week 1: baseline period (no added medications - to establish a baseline) * Weeks 2-4: double-blinded experimental period - participants receive either 1) high-dose Vitamin D3 + multivitamin, or 2) placebo + multivitamin. Participants also fill out a survey and have blood testing. * Weeks 5-7: open-label period - ALL participants receive high-dose Vitamin D3 + multivitamin. Participants also fill out a survey and may have blood testing. Specifically, our primary outcome is the change from baseline to experimental weeks 1-3 in the frequency of cluster headache attacks between placebo and high-dose vitamin D. Specific primary and secondary outcomes are listed below.
NCT05023460
The study is an investigator-initiated, prospective, randomized, placebo-controlled, double blind clinical trial that aims to investigate the effect of transcutaneous electrical nerve stimulation (TENS) and occipital nerve stimulation (ONS) on attack frequency and severity in patients with chronic cluster headache (CH). Study outline Month 1: Baseline. Establishment of a baseline profile of the participants CH attacks (severity, duration, medicine utilization etc), health-related quality of life (QoL) and symptoms of anxiety and depression. No active treatment. Follow-up visit after 30 days. Months 2-4: TENS period. All participants will receive TENS-treatment. Clinical follow-up visit by the end of month four. Months 5-7: Double-blinded, randomized experimental period. All participants will have an ONS-system (lead, impulse generator) implanted and will be randomized 1:1 to receive either 1) burst (paresthesia-free) ONS or 2) placebo (deactivated ONS system). Clinical follow-up visit by the end of month seven. Months 8-10: Open label period. All participants will receive tonic (conventional, paresthesia-inducing) ONS. Clinical follow-up visit by the end of month ten. During every study phase each participant will fill out a weekly electronic headache registration as well as answering questionnaires regarding health-related quality of life and symptoms of anxiety and depression before every follow-up visit.
NCT03944876
Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .
NCT06583395
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.
NCT04688775
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)
NCT06124534
The purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel BliStim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. This is a prospective, first in human study.
NCT05153876
Headache disorders are among the most prevalent medical conditions worldwide. The diagnosis of headache disorders is based on medical history taking. Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. Participants will provide a written description of their headache disorder. The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.
NCT04014634
Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.
NCT04970355
The main purpose of this study is to evaluate the efficacy of erenumab in participants with chronic cluster headache.
NCT06206772
Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, and bout recurrence happens in a circannual fashion. Notably, the mechanisms underlying the shift between the remission phase and cluster bout are poorly understood. Thus, the investigators aim to study brain connectivity in episodic cluster headache patients. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.
NCT02981173
The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.