Neurology
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The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. ⋯ We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients.
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The aim of the study was to determine whether various transient sensory and neuropsychological symptoms (SNS) were associated with migraine using a custom questionnaire. ⋯ The observed SNS seem to belong to a physiologic spectrum of multisensory phenomena. Some of these phenomena were significantly accentuated in patients with migraine and may therefore be termed migraine trait symptoms. However, these results will have to be confirmed in a prospective study with face-to-face interviews.
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Randomized Controlled Trial
rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate.
This double-blind, randomized, placebo-controlled study investigated the impact of repetitive transcranial magnetic stimulation (rTMS) on quality of life (QoL) of patients with fibromyalgia, and its possible brain metabolic substrate. ⋯ This study provides Class II evidence that rTMS compared with sham rTMS improves QoL in patients with fibromyalgia.
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Multicenter Study Observational Study
Risk factors for EEG seizures in neonates treated with hypothermia: a multicenter cohort study.
To assess the risk factors for electrographic seizures among neonates treated with therapeutic hypothermia for hypoxic-ischemic encephalopathy (HIE). ⋯ Electrographic seizures are common among neonates with HIE undergoing hypothermia and are difficult to predict based on clinical features. These results justify the recommendation for cEEG monitoring in neonates treated with hypothermia.