Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial

Yang, Huajun; Shi, Weixiong; Fan, Jingjing; Wang, Xiaoshan; Song, Yijun; Lian, Yajun; Shan, Wei; Wang, Qun

doi:10.1007/s13311-023-01353-9

Cited by 24 publications

(3 citation statements)

References 37 publications

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“…However, the stimulation frequency will be set at 1 Hz, and the intensity level will only elicit the minimum perceptible tingling sensation, creating the illusion of active stimulation. The National Institutes for Food and Drug Control (NIFDC)-certified taVNS device TVNS-100 (Xinzhile, Jiangxi, China) will be utilized for the taVNS procedure, with electrodes placed on both the inner and outer surfaces of the tragus in bilateral ears ( 43 ). Patients and caregivers will receive professional instructions on how to operate the stimulator and then perform the stimulation by themselves routinely.…”

Section: Methodsmentioning

confidence: 99%

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Effects of transcutaneous auricular vagus nerve stimulation and exploration of brain network mechanisms in children with high−functioning autism spectrum disorder: study protocol for a randomized controlled trial

Sun,

Li,

Zhai

et al. 2024

Front. Psychiatry

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BackgroundAutism Spectrum Disorders (ASD) are a collection of neurodevelopmental diseases characterized by poor social interaction and communication, a limited range of interests, and stereotyped behavior. High-functioning autism (HFA) indicates a subgroup of individuals with autism who possess cognitive and/or language skills that are within the average to above-normal range for their age. Transcutaneous auricular vagus nerve stimulation (taVNS) holds promise in children with HFA. However, few studies have used randomized controlled trials to validate the effectiveness of taVNS. Therefore, in this study, we intend to provide a study protocol to examine the therapeutic effects of taVNS in individuals diagnosed with HFA and to investigate the process of brain network remodeling in individuals with ASD using functional imaging techniques to observe alterations in large-scale neural networks.Methods and designWe planned to employ a randomized, double-blind experimental design, including 40 children receiving sham stimulation and 40 children receiving real stimulation. We will assess clinical scales and perform functional imaging examinations before and after the stimulation. Additionally, we will include age- and gender-matched healthy children as controls and conduct functional imaging examinations. We plan first to observe the therapeutic effects of taVNS. Furthermore, we will observe the impact of taVNS stimulation on the brain network.DiscussiontaVNS was a low-risk, easy-to-administer, low-cost, and portable option to modulate the vagus system. taVNS may improve the social performance of HFA. Changes in the network properties of the large-scale brain network may be related to the efficacy of taVNS.Clinical trial registrationhttp://www.chictr.org.cn, identifier ChiCTR2300074035.

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Section: Methodsmentioning

confidence: 99%

“…Patients remain quiet during each 30-minute session. The stimulation intensity will be adjusted to a level where patients experience the maximum tolerable intensity of pain (43)(44)(45). In contrast, the sham group will undergo a placebo procedure designed to mimic the active treatment condition.…”

Section: Interventionsmentioning

confidence: 99%

Effects of transcutaneous auricular vagus nerve stimulation and exploration of brain network mechanisms in children with high−functioning autism spectrum disorder: study protocol for a randomized controlled trial

Sun,

Li,

Zhai

et al. 2024

Front. Psychiatry

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“…VNS is designed to provide continuous, intermittent electrical stimulation to the vagus nerve at pre-defined parameters. This stimulation has been shown to reduce seizure frequency and severity in patients with drug-resistant epilepsy [ 73 , 74 ]. By altering the activity of brain regions involved in seizure generation, VNS helps to prevent the spread of abnormal electrical activity and disrupts the development of seizures [ 75 ].…”

Section: Vagus Nerve Stimulationmentioning

confidence: 99%

A Comprehensive Review of Emerging Trends and Innovative Therapies in Epilepsy Management

Ghosh,

Sinha,

Ghosh

et al. 2023

Brain Sciences

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Epilepsy is a complex neurological disorder affecting millions worldwide, with a substantial number of patients facing drug-resistant epilepsy. This comprehensive review explores innovative therapies for epilepsy management, focusing on their principles, clinical evidence, and potential applications. Traditional antiseizure medications (ASMs) form the cornerstone of epilepsy treatment, but their limitations necessitate alternative approaches. The review delves into cutting-edge therapies such as responsive neurostimulation (RNS), vagus nerve stimulation (VNS), and deep brain stimulation (DBS), highlighting their mechanisms of action and promising clinical outcomes. Additionally, the potential of gene therapies and optogenetics in epilepsy research is discussed, revealing groundbreaking findings that shed light on seizure mechanisms. Insights into cannabidiol (CBD) and the ketogenic diet as adjunctive therapies further broaden the spectrum of epilepsy management. Challenges in achieving seizure control with traditional therapies, including treatment resistance and individual variability, are addressed. The importance of staying updated with emerging trends in epilepsy management is emphasized, along with the hope for improved therapeutic options. Future research directions, such as combining therapies, AI applications, and non-invasive optogenetics, hold promise for personalized and effective epilepsy treatment. As the field advances, collaboration among researchers of natural and synthetic biochemistry, clinicians from different streams and various forms of medicine, and patients will drive progress toward better seizure control and a higher quality of life for individuals living with epilepsy.

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The adaptation of the desirability of outcome ranking for interventional clinical trials in epilepsy: A novel consumer‐led outcome measure

Vivash,

Johns,

O'Brien

et al. 2023

Epilepsia Open

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Interventional clinical trials in epilepsy are typically designed and powered to detect a change in seizure frequency as the primary endpoint, with little consideration given to other benefits or harms of the therapy, or impacts on common epilepsy comorbidities. Desirability of outcome ranking (DOOR) is a novel methodology for evaluating benefits and harms associated with introduction of a new treatment. Multiple outcomes are combined and the resulting combinations are ranked according to their desirability. Herein we describe the adaptation of DOOR for use in therapy trials in epilepsy. Consumers with epilepsy were presented with a selection of measures typically included in epilepsy trials and asked to rank their importance in terms of a desirable outcome and to identify interactions between different seizure control levels and other measures. Seizure control, adverse events, and psychiatric comorbidities were identified as most important, and combinations of these outcomes were ranked to form epilepsy‐DOOR. A separate consumer discussion group verified the appropriateness and accuracy of the ranking. The resultant epilepsy‐DOOR includes 60 possible outcomes, representing high granularity for the assessment of future interventions. It demonstrates the importance of consumer involvement in trial design and presents an alternative to seizure frequency for evaluating new treatments for epilepsy.

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Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial

Cited by 24 publications

References 37 publications

Effects of transcutaneous auricular vagus nerve stimulation and exploration of brain network mechanisms in children with high−functioning autism spectrum disorder: study protocol for a randomized controlled trial

Effects of transcutaneous auricular vagus nerve stimulation and exploration of brain network mechanisms in children with high−functioning autism spectrum disorder: study protocol for a randomized controlled trial

A Comprehensive Review of Emerging Trends and Innovative Therapies in Epilepsy Management

The adaptation of the desirability of outcome ranking for interventional clinical trials in epilepsy: A novel consumer‐led outcome measure

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