Tariq, Nauman

Abstract Background: There is a need for effective and affordable nondrug therapies for the acute treatment of migraine. Transnasal neuromodulation via evaporative cooling may modulate the sphenopalatine ganglion, which is implicated in migraine. The study aimed to evaluate the safety, tolerability, and optimal dose of this method for acute migraine treatment. Methods: A prospective, randomized, double-blind, multicenter study was conducted at 3 US sites. Subjects received 15 minutes of in-clinic treatment during a migraine attack. Twenty-four subjects were randomized into three groups: 24 liters per minute (LPM), 18 LPM, and 6 LPM. Pain and Most Bothersome Symptom (MBS) were recorded at baseline 2 and 24 hours post treatment. The primary endpoint was pain relief (PR) at 2 hours. Secondaryendpoints included tolerability, MBS relief and pain freedom (PF) at 2 hours and 24 hours Results: Eighty-seven adults with episodic migraine with or without aura were enrolled. PR at 2 hours without rescue medication (woRM) was reported by 89% (8/9) of the participants who received 6LPM. PR at 2 hwoRM was reported to be 56% (5/9) and 50% (3/6) in the 18LPM and 24LPM groups, respectively. PF at 2 hours woRM was reported by 44% (4/9) of participants in the 6LPM group, and no participants in the 18LPM or 24LPM group reported PF at 2 hours. MBS relief at 2 hwas 78% (7/9), 67% (6/9) and 50% (3/6) in the 16, 18 & 24LPM groups, respectively. No adverse events occurred in the 6LPM group,and none were serious or severe in any group. Moderate discomfort was reported by 11% (1/9) of the participants in the 6LPM group. In contrast, 33% (3/9) and 83% ofthe 18LPM and 24LPM groups reported moderate or severe discomfort, respectively. Zero, one, and two subjects discontinued the 15-minute session in the 6LPM, 18LPM, and 24LPM groups, respectively. The study was terminated early because of slow subject accrual. Conclusions: Lower flow rates during transnasal cooling were both effective and tolerable for acute migraine treatment. The study became a dose-ranging trial, with lower flow rates,showing greater efficacy. A future at-home study is planned. Trial Registration: ClinicalTrials.gov Identifier: NCT04936061; Registration date: June 15, 2021. The full study protocol can be accessed at https://clinicaltrials.gov/study/NCT04936061.

Object The utilization of endovascular treatment for ruptured intracranial aneurysms is expected to change since the publication of the International Subarachnoid Aneurysm Trial (ISAT) in 2002. The authors performed this analysis to determine the impact of ISAT results on treatment selection for ruptured intracranial aneurysms and associated in-hospital outcomes using nationally representative data. Methods We determined the national estimates of treatments used for ruptured intracranial aneurysms and associated in-hospital outcomes, length of stay, mortality, and cost incurred using the Nationwide Inpatient Survey (NIS) data. The NIS is the largest all-payer inpatient care database in the US and contains data from 986 hospitals approximating a 20% stratified sample of US hospitals. All the variables pertaining to hospitalization were compared between 2000–2002 and 2004–2006, and in-hospital outcomes were analyzed using multivariate analysis. Results In the 3-year periods prior to and after the ISAT, there were 70,637 and 77,352 admissions for ruptured intracranial aneurysms, respectively. There was a significant increase in endovascular treatment after publication of the ISAT (trend test, p < 0.0001) The in-hospital mortality for ruptured intracranial aneurysm admissions decreased from 27% to 24% (odds ratio [OR] 0.89, 95% CI 0.83–0.96, p = 0.003) after the publication of the ISAT. The cost of hospitalization after adjusting for procedures practices was not significantly higher after the publication of the ISAT ($21,437 vs $22,817, p < 0.89), but cost of hospitalization was higher in the post-ISAT period for patients undergoing endovascular procedure. Conclusions The results of the ISAT have been associated with a prominent change in practice patterns related to the treatment of ruptured aneurysms. The cost of hospitalization has increased and the mortality has decreased, presumably due to a larger proportion of patients receiving any treatment and endovascular treatment.