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Cluster Headache clinical trials

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NCT ID: NCT06277063 Not yet recruiting - Cluster Headache Clinical Trials

nVNS for the Prevention and Treatment of Primary Headache

Start date: March 10, 2024
Phase: N/A
Study type: Interventional

This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction. 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 attack and preventive 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.

NCT ID: NCT06206772 Recruiting - Cluster Headache Clinical Trials

Resting State Functional Connectivity in Cluster Headache

Start date: November 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT06200480 Recruiting - Migraine Clinical Trials

Nurse Intervention Trial

Start date: April 21, 2023
Phase: N/A
Study type: Interventional

This randomized open-label prospective study focus on headache patients initiating preventive treatment, where the treating physician identifies a need for follow-up visits in specialized healthcare. The study will clarify whether the implementation (compliance) and overall satisfaction of the patient are better with follow-up by a headache nurse compared to standard follow-up. Patients with signed written consent will be randomised to either group a: Telephone calls from nurse after two and 6 week or B. Patient-initiated follow-up by their general practitioner.

NCT ID: NCT06124534 Recruiting - Clinical trials for Chronic Cluster Headache

Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH

BONS
Start date: October 19, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06011811 Recruiting - Cluster Headache Clinical Trials

Cluster Headache Treatment Survey

Start date: June 29, 2023
Phase:
Study type: Observational

The objective of this study is to survey patients with cluster headache about treatment effectiveness and their views on treatments. Participants will complete one brief questionnaire online.

NCT ID: NCT05978258 Not yet recruiting - Cluster Headache Clinical Trials

A Close Examination of Patient Experiences in Cluster Headache Clinical Research

Start date: August 2024
Phase:
Study type: Observational

Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache 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 cluster headache. The data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.

NCT ID: NCT05868044 Recruiting - Clinical trials for Chronic Cluster Headache

REsponse to Combined SONS and ONS in Chronic Cluster headachE

RESPONSE
Start date: May 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the safe use of a novel cranio-facial Peripheral Nerve Stimulator PNS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PNS System for the treatment of chronic cluster headache.

NCT ID: NCT05857098 Not yet recruiting - Cluster Headache Clinical Trials

Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients

DETECT
Start date: May 31, 2023
Phase:
Study type: Observational

The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised. Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor…) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity…). As it is a feasibility study, only 5 patients will be included.

NCT ID: NCT05780450 Recruiting - COVID-19 Clinical Trials

Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This study aims to verify the efficacy / effectiveness of treatment with transcranial direct therapy (TDCS) in patients with Persistent Covid who present headaches, migraines and chronic pain, such as arthralgias and myalgias. Transcranial Direct Therapy is used in the field of Physiotherapy and Rehabilitation, with results that prove to be effective for the treatment of patients suffering from symptoms such as migraines, headaches, chronic pain, fibromyalgia or chronic neuropathic pain. As can be seen, in the case of patients with Persistent Covid we find several of these symptoms, so it is suggested that, if Transcranial Direct Current Therapy (TDCs) is giving such good results, relieving these symptoms, why can not give such good results and help so much in patients with Persistent Covid, If many of the symptoms are the same, even if the origin or cause is different.

NCT ID: NCT05477459 Not yet recruiting - Clinical trials for Chronic Cluster Headache

LSD to Improve Cluster Headache Impact Trial

LICIT
Start date: January 2024
Phase: Phase 2
Study type: Interventional

This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH). It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period. Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH. Additional objectives: - To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH. - To explore the exposure-response relationship of 25μg LSD in cCH. - To assess the effect of treatment with 25μg LSD on hypothalamic functional connectivity in patients with cCH, using resting state functional magnetic resonance imaging (rsMRI). - To explore cost-effectiveness of treatment with LSD in cCH. - To evaluate the efficacy of LSD on health-related quality of life.