One-Year Consistent Safety, Utilization, and Efficacy Assessment of Remote Electrical Neuromodulation (REN) for Migraine Treatment.

INTRODUCTION: Migraine is a chronic neurological disorder causing severe pain and disability in more than a billion people worldwide. Ideal treatment should provide long-term efficacy with minimal side effects. Previous studies indicate that remote electrical neuromodulation (REN) is an efficacious and safe treatment option for the acute treatment of migraine in clinical practice. This study examined long-term safety, utilization, and efficacy of REN during 12 consecutive usage months. METHODS: Data from patients with migraine across the USA using REN to treat their migraine attacks were electronically collected from the Nerivio® device. All patients who used REN during 12 consecutive months were included, and data were compared across months. Safety was assessed by the number and type of adverse events. Utilization was measured by the number of monthly treatments. Efficacy was evaluated as consistent change in headache pain intensity, functional disability, and disappearance of associated symptoms from baseline to 2 h post treatment. RESULTS: Data were analyzed from 409 people living with migraine who treated with REN for 12 consecutive months, performing a total of 39,531 treatments. The incidence of device-related adverse events (dAEs) was 1.96% (8/409), including two negligible (0.49%), five mild (1.22%), one moderate (0.24%), and no severe events. All patients continued treatment with REN despite dAEs. One-year average monthly utilization was 8.05 treatments (SD 1.15). Month-to-month utilization did not change during 12 months of consecutive use [F(4.895, 1997.204) = 2.014, p = 0.075, repeated-measures ANOVA]. One-year average efficacy showed 74.1% of users reported consistent 2-h pain relief, and 26.0% reported consistent pain freedom. Month-to-month pain relief and pain freedom did not change during 12 months of consecutive use [F(11, 1069) = 0.55, p = 0.873 and F(11, 1295) = 0.69, p = 0.750 respectively; generalized linear mixed model analysis]. CONCLUSION: REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option for the long-term management of this chronic disease. TRIAL REGISTRATION NUMBER: NCT05760638.

Migraine is a chronic disease leading to decades of significant disability, thus requiring safe, effective, and tolerable treatment for years. Remote electrical neuromodulation (REN) is a smartphone-controlled wearable device (Nerivio^®) indicated for the acute and/or preventive treatment of migraine in patients 12 years of age or older. It is a prescribed, self-administered device for use at the onset of migraine headache or aura for acute treatment, or every-other-day for preventive treatment. Treatments are automatically registered in the REN app and database, and users can prospectively report subjective migraine indicators and response to the treatment in the REN app, at treatment onset and again 2 h later. This study analyzed data from people who used REN for the acute treatment of their migraine attacks at least once per month, for at least 12 consecutive months. Data from 409 patients who met the study criteria and performed a total of 39,531 treatments was analyzed. Safety was measured by the incidence of device-related adverse events, which was 1.96%. Severe device-related adverse events were not reported, and all patients continued treating after the events. Efficacy over the year showed that 74.1% of the patients reported consistent pain relief, and 26.0% reported consistent pain freedom. Average monthly utilization over the year was 8.05 treatments. Month-to-month pain relief, pain freedom, and utilization did not differ between 12 months of consecutive use. These results show that REN is a safe and well-tolerated treatment, with stable efficacy and utilization over at least 1 year, making it an advantageous non-drug option for the long-term management of migraine.

Oculomotor, Vestibular, and Reaction Time Effects of Sports-Related Concussion: Video-Oculography in Assessing Sports-Related Concussion.

OBJECTIVE: The purpose of the study was to test the ability of oculomotor, vestibular, and reaction time (OVRT) metrics to serve as a concussion assessment or diagnostic tool for general clinical use. SETTING AND PARTICIPANTS: Patients with concussion were high school-aged athletes clinically diagnosed in a hospital setting with a sports-related concussion (n = 50). Control subjects were previously recruited male and female high school student athletes from 3 local high schools (n = 170). DESIGN: Video-oculography was used to acquire eye movement metrics during OVRT tasks, combined with other measures. Measures were compared between groups, and a subset was incorporated into linear regression models that could serve as indicators of concussion. MEASURES: The OVRT test battery included multiple metrics of saccades, smooth pursuit tracking, nystagmoid movements, vestibular function, and reaction time latencies. RESULTS: Some OVRT metrics were significantly different between groups. Linear regression models distinguished control subjects from concussion subjects with high accuracy. Metrics included changes in smooth pursuit tracking, increased reaction time and reduced saccade velocity in a complex motor task, and decreased optokinetic nystagmus (OKN) gain. In addition, optokinetic gain was reduced and more variable in subjects assessed 22 or more days after injury. CONCLUSION: These results indicate that OVRT tests can be used as a reliable adjunctive tool in the assessment of concussion and that OKN results appear to be associated with a prolonged expression of concussion symptoms.

Rare ocular manifestation in a case of West Nile virus meningoencephalitis.

West Nile Virus (WNV) is an arthropod-borne flavivirus, which causes flu-like illness and is sporadically associated with encephalitis. Transmission to humans occurs following a bite from an infected mosquito, which acquires the virus after feeding on dead birds. WNV meningoencephalitis is a rare infection with a neuroinvasive disease occurring in less than 1% of the cases, with varied presentations including aseptic meningitis, meningoencephalitis, and acute flaccid paralysis. Chorioretinitis is the most common eye finding in this infection, while other ocular manifestations have been rarely reported in the literature. We present the first case report of WNV meningoencephalitis, with rare ocular manifestations of acute hemorrhagic conjunctivitis, bilateral subconjunctival hemorrhages, and nystagmus. The rare ocular findings of acute hemorrhagic conjunctivitis, bilateral subconjunctival hemorrhages, and nystagmus diagnosed in our case can guide clinicians toward early diagnosis of WNV meningoencephalitis, while serologic testing is still pending.

Ketamine use in the treatment of refractory status epilepticus.

Refractory status epilepticus (RSE) occurs when status epilepticus (SE) fails to respond to appropriate therapy with typical antiepileptic drugs (AEDs). Animal studies have shown ketamine to be a highly efficacious agent in this setting, but very few case reports describe use of ketamine in human SE or RSE. We report a retrospective review of 11 patients who were treated for RSE with ketamine infusion in addition to other standard AEDs over a nine-year period. Data collection included age, gender, history of epilepsy, etiology of RSE, daily dose of ketamine, co-therapeutic agents, duration of seizures, treatment response, and disposition. RSE was successfully terminated in all 11 patients treated with ketamine. Dosing ranged from 0.45 mg/kg/h to 2.1 mg/kg/h based upon the preference of the treating clinician and response to therapy, with maximal daily doses ranging from 1392 mg to 4200 mg. Ketamine was the last AED used prior to resolution of RSE in 7/11 (64%) cases. In the remaining four cases, one other AED was added after ketamine infusion had begun. Time from ketamine initiation to seizure cessation ranged from 4 to 28 days (mean=9.8, SD=8.9). In 7/11 patients, RSE was resolved within one week of starting therapy. Administration of ketamine was uniformly associated with improvement in hemodynamic stability. Six of the seven patients (85%) who required vasopressors during early treatment for RSE were able to be weaned from vasopressors during ketamine infusion. No acute adverse effects were noted. These findings suggest that ketamine may be a safe and efficacious adjunctive agent in the treatment of RSE.

The efficacy of topiramate in adult refractory status epilepticus: experience of a tertiary care center.

Refractory status epilepticus (RSE) occurs in patients with SE when they fail to respond to traditional medical therapy. Because there are very few case reports of topiramate (TPM) treatment of RSE in adult patients, we examined our experience with TPM with regard to its safety and efficacy in seizure termination in RSE in an adult patient population. We report a retrospective review of 35 adult patients with RSE who were treated with TPM in addition to other antiepileptic drugs (AEDs) between 2003 and 2010. After failure of initial treatments of benzodiazepines and weight-based intravenous loading doses of standard AEDs, TPM tablets were crushed and administered via nasogastric tube. Data were collected on age, gender, history of epilepsy, etiology of RSE, daily dose of TPM, co-therapeutic agents, treatment response, and disposition. Following initiation of TPM use and discontinuation of continuous intravenous anesthetics with no additional AEDs administered, cumulative cessation of RSE in patients was 4/35 (11%) at one day, 10/35 (29%) at two days, and 14/35 (40%) at three days. However, when including all patients and comparing the two patient groups in which RSE was or was not terminated within three days of initiating TPM as the last or not last AED given, there was no significant difference. Time to TPM response was not associated with the type of seizures, etiology of SE, or whether there was a history of epilepsy. There were no documented side effects or complications of therapy with TPM. This study provides support for the use of TPM as an adjunctive agent in the treatment of RSE.

Refractory status epilepticus treated with vagal nerve stimulation: case report.

BACKGROUND AND IMPORTANCE: Status epilepticus (SE) refractory to medical treatment has a high mortality rate and few effective treatments. CLINICAL PRESENTATION: We describe the implantation of a vagal nerve stimulator to help terminate a case of refractory SE. A 23-year-old man was in SE for 3 weeks without being able to be weaned from intravenous anesthetic agents. After implantation of a vagal nerve stimulator, SE soon terminated, and the patient could be weaned from sedative agents and made a full recovery. CONCLUSION: Vagal nerve stimulator should be considered in cases of refractory SE.