Transcutaneous vagus nerve stimulation in the treatment of drug-resistant epilepsy. 2021

Randi von Wrede, and Rainer Surges
Department of Epileptology, University Hospital Bonn, Venusberg Campus 1, 53127 Bonn, Germany. Electronic address: randi.von.wrede@ukbonn.de.

Epilepsy is a common chronic neurological disease with a high burden of illness. Invasive vagus nerve stimulation (iVNS) is a well-established treatment option in patients with epilepsy (PWE). More recently, transcutaneous vagus nerve stimulation (tVNS) was introduced, an alternative option which is particularly interesting because it does not require surgery and is instantaneously removable. Here, we thoroughly reviewed clinical data on efficacy and safety of tVNS in epilepsies. Five prospective trials in 118 patients with drug-resistant epilepsies and 3 randomized controlled trials in 280 patients with drug-resistant epilepsies were carried out. Study protocols were heterogeneous in terms of patients' characteristics, used device, stimulation parameters, study duration and endpoints. Seizure reduction amounted up to 64%, with responder rates (seizure reduction ≥50%) up to 65%. Seizure freedom was reached in up to 24%, and even to 31% in a small pediatric study group. Seizure severity scores were provided in 4 studies, showing significant improvement in two of them. Adverse side effects were mostly headache, ear pain and skin alteration and rated as mild to moderate. Drowsiness might be depend on stimulation intensity. Quality of life scores reflecting burden of illness showed significant improvement in two studies. Efficacy and safety of tVNS in PWE has to be interpreted as promising. Multicenter randomized double-blind clinical trials with standardized stimulation protocols and long-term follow-up studies are necessary to finally assess tVNS treatment outcome in drug-resistant epilepsies.

UI MeSH Term Description Entries
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D004364 Pharmaceutical Preparations Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form. Drug,Drugs,Pharmaceutical,Pharmaceutical Preparation,Pharmaceutical Product,Pharmaceutic Preparations,Pharmaceutical Products,Pharmaceuticals,Preparations, Pharmaceutical,Preparation, Pharmaceutical,Preparations, Pharmaceutic,Product, Pharmaceutical,Products, Pharmaceutical
D004561 Transcutaneous Electric Nerve Stimulation The use of specifically placed small electrodes to deliver electrical impulses across the SKIN to relieve PAIN. It is used less frequently to produce ANESTHESIA. Analgesic Cutaneous Electrostimulation,Electric Stimulation, Transcutaneous,Electroanalgesia,Percutaneous Electric Nerve Stimulation,TENS,Transdermal Electrostimulation,Electrical Stimulation, Transcutaneous,Percutaneous Electrical Nerve Stimulation,Percutaneous Electrical Neuromodulation,Percutaneous Neuromodulation Therapy,Transcutaneous Electrical Nerve Stimulation,Transcutaneous Nerve Stimulation,Cutaneous Electrostimulation, Analgesic,Electrical Neuromodulation, Percutaneous,Electrical Neuromodulations, Percutaneous,Electroanalgesias,Electrostimulation, Analgesic Cutaneous,Electrostimulation, Transdermal,Nerve Stimulation, Transcutaneous,Neuromodulation Therapy, Percutaneous,Neuromodulation, Percutaneous Electrical,Neuromodulations, Percutaneous Electrical,Percutaneous Electrical Neuromodulations,Percutaneous Neuromodulation Therapies,Stimulation, Transcutaneous Electric,Stimulation, Transcutaneous Nerve,Therapy, Percutaneous Neuromodulation,Transcutaneous Electric Stimulation,Transcutaneous Electrical Stimulation
D004827 Epilepsy A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313) Aura,Awakening Epilepsy,Seizure Disorder,Epilepsy, Cryptogenic,Auras,Cryptogenic Epilepsies,Cryptogenic Epilepsy,Epilepsies,Epilepsies, Cryptogenic,Epilepsy, Awakening,Seizure Disorders
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014630 Vagus Nerve The 10th cranial nerve. The vagus is a mixed nerve which contains somatic afferents (from skin in back of the ear and the external auditory meatus), visceral afferents (from the pharynx, larynx, thorax, and abdomen), parasympathetic efferents (to the thorax and abdomen), and efferents to striated muscle (of the larynx and pharynx). Cranial Nerve X,Pneumogastric Nerve,Tenth Cranial Nerve,Nerve X,Nervus Vagus,Cranial Nerve, Tenth,Cranial Nerves, Tenth,Nerve X, Cranial,Nerve Xs,Nerve, Pneumogastric,Nerve, Tenth Cranial,Nerve, Vagus,Nerves, Pneumogastric,Nerves, Tenth Cranial,Nerves, Vagus,Pneumogastric Nerves,Tenth Cranial Nerves,Vagus Nerves,Vagus, Nervus
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D055536 Vagus Nerve Stimulation An adjunctive treatment for PARTIAL EPILEPSY and refractory DEPRESSION that delivers electrical impulses to the brain via the VAGUS NERVE. A battery implanted under the skin supplies the energy. Vagal Nerve Stimulation,Nerve Stimulation, Vagal,Nerve Stimulation, Vagus,Nerve Stimulations, Vagal,Nerve Stimulations, Vagus,Stimulation, Vagal Nerve,Stimulation, Vagus Nerve,Stimulations, Vagal Nerve,Stimulations, Vagus Nerve,Vagal Nerve Stimulations,Vagus Nerve Stimulations

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