Search Results (6)

Background: Occipital nerve stimulation (ONS) is an effective therapy for patients with refractory chronic cluster headache (rCCH); however, it is not without complications, and to date, there are no conclusive findings regarding factors that would allow the prediction of treatment response. The primary objective of this study is to identify such factors to improve patient selection. Methods: This single-center prospective observational study will be conducted at the Department of Neurology, Hospital Universitario La Paz (Madrid, Spain). Given the low prevalence of rCCH, a convenience sampling approach will be adopted, with an expected enrollment of a minimum of 15 patients over 24 months of the study. The study is structured into three periods: Pre-ONS (pre-implantation), ONS (implantation), and Post-ONS (follow-up at 12 months). During the pre-implantation phase, patients will undergo a multidimensional assessment encompassing structural 3T brain magnetic resonance imaging (MRI), blood analysis (calcitonin gene-related peptide (CGRP), pituitary adenylate cyclase-activating peptide 38 (PACAP38), and vasoactive intestinal peptide (VIP)), neuropsychological evaluation, auditory evoked potentials, algometry (pressure pain threshold, temporal summation, conditioned pain modulation), and transcutaneous electrical nerve stimulation (TENS). Follow-up visits will be conducted at 3, 6, and 12 months post-implantation. Results: This study aims to identify biomarkers or their combinations capable of reliably predicting patients who would benefit from ONS. Conclusions: Through this multidimensional assessment, this study seeks to identify predictive factors of response to ONS, thereby improving patient selection, optimizing healthcare resources, and advancing the understanding of treatment response mechanisms. Full article

Background/Objectives: Cluster headache (CH) is a debilitating primary headache disorder characterized by severe unilateral pain attacks. Chronic CH (CCH) poses significant treatment challenges, especially in refractory cases. Neuromodulation, including repetitive transcranial magnetic stimulation (rTMS), offers a potential alternative; however, evidence for its efficacy in CCH is lacking. Methods: A randomized, double-blind, placebo-controlled, crossover pilot study was conducted. Eligibility criteria included patients with refractory CCH (rCCH), who were then randomized to receive two treatment sequences: A, rTMS followed by sham stimulation, or B, sham followed by rTMS, separated by a one-month washout, with a follow-up period of 3 months. The primary endpoint was to analyze efficacy by assessing the change in the number of attacks per week (APW). Secondary endpoints included treatment tolerability and changes in intensity, duration, and use of rescue medication. The trial was registered with ClinicalTrials.gov (NCT06917144). Results: Eight patients were enrolled and randomized with a 50% probability of assignment to either treatment arm. Despite this, five patients were allocated to sequence A and three to sequence B. Three patients completed the entire study; five received treatment with rTMS and six with sham. The APW change during rTMS showed a change of (mean ± SD) +2.2 (10.8) attacks per week (p = 0.672). Two patients achieved complete remission during the rTMS phase, though symptoms returned by the washout period. In comparison with sham, the difference was also not statistically significant. No significant changes were observed in secondary endpoints. Side effects (two cases) were mild and transient. Conclusions: This pilot study suggests that rTMS may provide clinical benefits for rCCH in selected cases, though its effects seem transient. Adherence to treatment remains a critical challenge. Full article

Headaches are a very common condition that most people will experience many times during their lives. This article presents the primary headaches, which are a large group of diseases where the headache is not a symptom of another known disease. Tension-type headache affects approximately 80% of the general population, and the prevalence of migraine is estimated at 10–12%. Clinical data and experience to date have demonstrated that botulinum toxin may be an effective prophylactic treatment for chronic headache types. It has been used in neurology for the treatment of dystonia and blepharospasm. Now it has been approved to treat chronic migraine and has been shown to confer significant benefit in refractory cases. Based on clinical experience botulinum toxin has also been tried in other headache disorders. While it is intuitively attractive to think that due to its effect on pain by sensory modulation, there may also be efficacy in its use in chronic tension-type headache and cluster headache, so far, there is little evidence to support this. Botulinum toxin is effective in pain control through its interaction with the SNARE complex, which inhibits the release of neurotransmitters, such as glutamate, substance P and calcitonin gene-related peptide. OnabotulinumtoxinA is effective not only in headache frequency and pain intensity but in other parameters, including quality of life. Full article

Occipital nerve stimulation (ONS) is a surgical treatment proposed for drug-resistant chronic cluster headache (drCCH). Long-term series assessing its efficacy are scarce. We designed a retrospective observational study with consecutive sampling, evaluating the follow-up of 17 drCCH patients who underwent ONS. Our main endpoint was the reduction the rate of attacks per week. We also evaluated the pain intensity through the Visual Analogue Scale (VAS), patient overall perceived improvement and decrease in oral medication intake. After a median follow-up of 6.0 years (4.5–9.0), patients decreased from a median of 30 weekly attacks to 22.5 (5.6–37.5, p = 0.012), 7.5 at 1 year (p = 0.006) and 15.0 at the end of follow-up (p = 0.041). The VAS decreased from a median of 10.0 to 8.0 (p = 0.011) at three months, to 7.0 (p = 0.008) at twelve months and 7.0 (p = 0.003) at the end of the follow-up. A total of 23.5% had an overall perceived improvement of ≥70% at 3 months, 41.2% at 1 year and 27.8% at the end of follow-up. Reducing prophylactic oral medication was possible in 76.5% and it was stopped in 17.7%. Triptan use decreased in all the responder patients and 17.7% stopped its intake. A total of 41.2% presented mild adverse events. In conclusion, our long-term experience suggests that ONS could be an interesting option for drCCH-selected patients, as it is a beneficial and minimally invasive procedure with no serious adverse events. Full article

Objective: The aim of this paper is to describe the progressive changes of chronic cluster headaches (CHs) in a patient who is being treated by a multimodal approach, using pharmacology, neurostimulation and physiotherapy. Subject: A male patient, 42 years of age was diagnosed with left-sided refractory chronic CH by a neurologist in November 2009. In June 2014, the patient underwent a surgical intervention in which a bilateral occipital nerve neurostimulator was implanted as a treatment for headache. Methods: Case report. Results: Primary findings included a decreased frequency of CH which lasted up to 2 months and sometimes even without pain. Besides this, there were decreased levels of anxiety, helplessness (PCS subscale) and a decreased impact of headache (HIT-6 scale). Bilateral pressure pain thresholds (PPTs) were improved along with an increase in strength and motor control of the neck muscles. These improvements were present at the conclusion of the treatment and maintained up to 4 months after the treatment. Conclusions: A multimodal approach, including pharmacology, neurostimulation and physiotherapy may be beneficial for patients with chronic CHs. Further studies such as case series and clinical trials are needed to confirm these results. Full article

In a number of patients continuous medical treatment will fail to effectively control attacks of chronic cluster headache. By neuromodulative procedures, e.g., deep brain stimulation and bilateral occipital nerve stimulation, it is possible to reduce the intensity and frequency of cluster attacks. Occipital nerve stimulation is less invasive and carries a lower risk. Both methods have shown favourable results in small case series. Ablative procedures are no longer recommended. Other neuromodulatory procedures, such as spinal cord and vagal nerve stimulation, need to prove their effectiveness in further studies. Stimulation of the sphenopalatine ganglion may may offer a means of terminating cluster headache attacks. The small numbers of affected individuals, the heterogeneity of cluster headache as a disease and the difficulty of conducting true blinded prospective trials still render evidence-based recommendations for neuromodulative therapies impossible. Full article