CandeSpartan Study: Candesartan Spanish Response-prediction and Tolerability study in migraine.

INTRODUCTION: Effectiveness of candesartan in migraine prevention is supported by two randomized controlled trials. We aimed to assess the effectiveness, tolerability, and response predictors of candesartan in the preventive treatment of migraine. METHODS: Observational, multicenter, prospective cohort study. The 50%, 75% and 30% responder rates, between weeks 8-12 and 20-24, were compared with the baseline. Treatment emergent adverse effects were systematically evaluated. Response predictors were estimated by multivariate regression models. RESULTS: Eighty-six patients were included, 79.1% females, aged 39.5 (inter-quartile range [IQR] 26.3-50.3), with chronic migraine (43.0%), medication overuse headache (55.8%) and a median of two (inter-quartile range: 0.75-3) prior preventive treatments. At baseline patients had 14 (10-24) headache and 8 (5-11) migraine days per month. The 30%, 50% and 75% responder rates were 40%, 34.9% and 15.1% between weeks 8-12, and 48.8%, 36%, and 18.6% between weeks 20-24. Adverse effects were reported by 30 (34.9%) and 13 (15.1%) patients between weeks 0-12 and 12-24, leading to discontinuation in 15 (17.4%) patients. Chronic migraine, depression, headache days per month, medication overuse headache, and daily headache at baseline predicted the response between weeks 20-24. CONCLUSION: Candesartan effectiveness and tolerability in migraine prevention was in line with the clinical trials' efficacy.Trial registration: The study protocol is registered in ClinicalTrials.gov (NCT04138316).

Long-Term Results of Cortical Motor Stimulation for Neuropathic Peripheral and Central Pain: Real-World Evidence From Two Independent Centers.

BACKGROUND AND OBJECTIVES: Cortical motor stimulation (CMS) is used to modulate neuropathic pain. The literature supports its use; however, short follow-up studies might overestimate its real effect. This study brings real-world evidence from two independent centers about CMS methodology and its long-term outcomes. METHODS: Patients with chronic refractory neuropathic pain were implanted with CMS. The International Classification of Headache Disorders 3rd Edition was used to classify craniofacial pain and the Douleur Neuropathique en 4 Questions Scale score to explore its neuropathic nature. Demographics and clinical and surgical data were collected. Pain intensity at 6, 12, and 24 months and last follow-up was registered. Numeric rating scale reduction of ≥50% was considered a good response. The Clinical Global Impression of Change scale was used to report patient satisfaction. RESULTS: Twelve males (38.7%) and 19 females (61.3%) with a mean age of 55.8 years (±11.9) were analyzed. Nineteen (61.5%) were diagnosed from painful trigeminal neuropathy (PTN), and seven (22.5%) from central poststroke pain. The mean follow-up was 51 months (±23). At 6 months, 42% (13/31) of the patients were responders, all of them being PTN (13/19; 68.4%). At last follow-up, only 35% (11/31) remained responders (11/19 PTN; 58%). At last follow-up, the global Numeric rating scale reduction was 34% ( P = .0001). The Clinical Global Impression of Change scale punctuated 2.39 (±0.94) after 3 months from the surgery and 2.95 (±1.32) at last follow-up ( P = .0079). Signs of suspicious placebo effect were appreciated in around 40% of the nonresponders. CONCLUSION: CMS might show long-term efficacy for neuropathic pain syndromes, with the effect on PTN being more robust in the long term. Multicentric clinical trials are needed to confirm the efficacy of this therapy for this and other conditions.

Occipital nerve stimulation and deep brain stimulation for refractory cluster headache: a prospective analysis of efficacy over time.

OBJECTIVE: Occipital nerve stimulation (ONS) and deep brain stimulation (DBS) are widely used surgical treatments for chronic refractory cluster headache (CH). However, there is little literature regarding long-term follow-up of these treatments. METHODS: The authors describe two prospective cohorts of patients with refractory CH treated with ONS and DBS and compare preoperative to postoperative status at 6 and 12 months after the surgery and at final follow-up. Efficacy analysis using objective and subjective variables is reported, as well as medication reduction and complications. RESULTS: The ONS group consisted of 13 men and 4 women, with a median age of 44 years (range 31-61 years). The median number of attacks per week (NAw) before surgery was 28 (range 7-70), and the median follow-up duration was 48 months. The DBS group comprised 5 men and 2 women, with a median age of 50 years (range 29-64 years). The median NAw before surgery was 56 (range 14-140), and the median follow-up was 36 months. The NAw and visual analog scale score were significantly reduced for the ONS and DBS groups after surgery. However, while all the patients from the DBS group were considered responders at final follow-up, with more than 85% being satisfied with the treatment, approximately 29% of initial responders to ONS became resistant by the final follow-up (p = 0.0253). CONCLUSIONS: ONS is initially effective as a treatment for refractory CH, although a trend toward loss of efficacy was observed. No clear predictors of good clinical response were found in the present study. Conversely, DBS appears to be effective and provide a more stable clinical response over time with an acceptable rate of surgical complications.

Efficacy of Sphenopalatine Ganglion Radiofrequency in Refractory Chronic Cluster Headache.

BACKGROUND: In the literature, there are only short series of radiofrequency of the sphenopalatine ganglion (SPG) to treat chronic refractory cluster headache (CCHr) with variable results. Furthermore, there is no consensus on which methodology to use: radiofrequency ablation (RFA) or pulsed radiofrequency (PRF). METHODS: We conducted a prospective analysis of 37 patients with CCHr who underwent RFA or PRF of the SPG in our center between 2004 and 2015. RESULTS: The mean age of the patients was 40 years (range, 26-59 years). PRF was performed in 24 patients, and RFA was performed in 13 patients. A total of 5 patients (13.5%) experienced complete clinical relief of both pain and parasympathetic symptoms, 21 patients (56.8%) had partial and transient relief, and 11 patients (29.7%) did not improve. There was no evidence of significant superiority of one radiofrequency modality over the other (P = 0.48). There were no complications associated with the technique. The passage of time tended to decrease the efficacy of both techniques (P < 0.001). The mean follow-up was 68.1 months (range, 15-148 months). To our knowledge, this is the series with the largest number of patients and the longest follow-up period published in the literature. CONCLUSIONS: Radiofrequency of the SPG is a safe, fast, and partially effective method for the treatment of CCHr. Given its low rate of complications and its low economic cost, we think it should be one of the first invasive treatment options, prior to techniques with greater morbidity and mortality, such as neuromodulation.