Transcutaneous vagus nerve stimulation for refractory epilepsy: a randomized controlled trial

Author(s):  
Peijing Rong ◽  
Aihua Liu ◽  
Jianguo Zhang ◽  
Yuping Wang ◽  
Wei He ◽  
...  

Abstract This trial was designed to test the safety and effectiveness of transcutaneous auricular vagus nerve stimulation (ta-VNS) for patients with refractory epilepsy. Pre-trial:144 patients were randomly assigned to ta-VNS group (n=98) or transcutaneous auricular non-vagus nerve stimulation (tn-VNS) control group (n=46). Treatment was conducted twice per day for 24 weeks. After 8, 16 and 24 weeks of treatment,the patients were evaluated according to the Modified Engel Scale (four classes). After 8 weeks,according to the medical ethic design, patients in tn-VNS group were switched into ta-VNS group uniquely. After 8 weeks’ treatment 41.0% and 27.5% of patients from ta-VNS and tn-VNS groups, respectively, experienced reduction in seizure frequency that reached I, II and III levels according to the standards of the Modified Engel Scale compared with the baselines, indicating significant difference in seizure reduction between the two groups. After 24 weeks of treatment, ta-VNS patients had a 47.7% reduction, and tn-VNS, with an additional 16 weeks of treatment, reached 47.5% in reduction. After 8 weeks’ treatment, the percentages of average seizure frequency in ta-VNS and tn-VNS were reduced by 42.6% and 11.5% respectively, providing a statistically significant difference in the results between the two groups (P<0.05). In addition, there were significant improvements in electroencephalograph (EEG) and the quality of daily life of the patients after treatment. The results show that this ta-VNS treatment can effectively reduce the frequency of seizures and improve the patient's quality of life. This may be an effective treatment for refractory epilepsy. At the same time,it is also safe,economic, and widely applicable.

2013 ◽  
Vol 71 (1) ◽  
pp. 25-30 ◽  
Author(s):  
Murilo S. Meneses ◽  
Samanta F. B. Rocha ◽  
Cristiane Simão ◽  
Heraldo Nei Hardt Laroca dos Santos ◽  
Cleudi Pereira ◽  
...  

INTRODUCTION: Refractory epilepsy accounts for 20 to 30% of epilepsy cases and remains a challenge for neurologists. Vagus nerve stimulation (VNS) is an option for palliative treatment. OBJECTIVE: It was to study the efficacy and tolerability of VNS in patients implanted with a stimulator at the Curitiba Institute of Neurology (INC). METHODS: A case study of six patients with refractory epilepsy submitted to a VNS procedure at the INC in the last four years was described and discussed. RESULTS: Mean age at time of implantation was 29 years. Mean follow-up was 26.6 months. Seizure frequency decreased in all patients (40-50% (n=2) and >80% (n=4)). Three patients no longer required frequent hospitalizations. Two patients previously restricted to wheelchairs started to walk, probably because of improved mood. CONCLUSION: In this population, VNS proved to be a sound therapeutic option for treating refractory epilepsy.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Charles Ethan Paccione ◽  
Lien My Diep ◽  
Audun Stubhaug ◽  
Henrik Børsting Jacobsen

Abstract Background Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM. Methods The study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N = 56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N = 56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography-measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life. Discussion The described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited. Trial registration ClinicalTrials.govNCT03180554. Registered on August 06, 2017.


2019 ◽  
Vol 28 (04) ◽  
pp. 230-234
Author(s):  
Bruno Toshio Takeshita ◽  
Carolina Oldoni ◽  
Rafaella Do Rosario Tacla ◽  
Karina Slompo ◽  
Camilla Von Steinkirch ◽  
...  

Approximately 33% of patients with epilepsy do not respond to treatment with a single antiepileptic drug. Many of these patients can benefit from neurosurgical treatment. However, not all patients are candidates for surgery, and in these cases vagus nerve stimulation (VNS) presents as a good therapeutic option. Objectives: Evaluation of efficiency, tolerability and safety in the control of seizures after VNS implantation in patients from a reference hospital. Methods: cross-sectional study examined 20 patients who underwent implantation of the VNS in our facilities between 2007 and 2014. Proportions and chi-square test were applied (statistical significance level set to p ≤ 0.05). Results: Mean follow-up was 31.3 months. Seizure frequency decreased in 55% of the patients. Among them, 11 patients believed that VNS had improved their quality of life. The mean reduction reported by other patients was 78.3%. More than 30% reported no adverse effects. About 70% of patients no longer required hospitalizations and 95% reported reduction in the number of hospitalizations. Conclusion: In this population, VNS proved to be a good option in the treatment of refractory epilepsy and also in providing a significant improvement in quality of life, (reduction of seizures and hospitalizations), mood, attention and memory, which directly reflects on their social and cognitive.


2020 ◽  
Author(s):  
Charles Ethan Paccione ◽  
Lien My Diep ◽  
Audun Stubhaug ◽  
Henrik Børsting Jacobsen

Abstract BackgroundChronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different non-invasive vagal nerve stimulation techniques for the treatment of FM.MethodsThe study will use a randomized, single blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRBTM) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N=112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N=56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N=56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pain-pressure limit determined by computerized pressure cuff algometry, blood pressure, and health related quality of life.DiscussionThe described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited.Trial registrationClinicalTrials.gov Identifier: NCT03180554; Date of Registration: 08/06/2017


Author(s):  
Mehdi Qiabi ◽  
Alain Bouthillier ◽  
Lionel Carmant ◽  
Dang Khoa Nguyen

Purpose:Retrospective study assessing the efficacy and tolerability of vagus nerve stimulation (VNS) for the treatment of refractory epilepsy at Notre-Dame Hospital.Methodology:Chart review of all adult epileptic patients treated by VNS with ≥ 1 year follow-up. Responders were defined as patients with ≥ 50% reduction of baseline seizure frequency.Results:Thirty-four patients (14M; mean age = 29.9 yrs) received a VNS. Sub-pectoralis implantation (n = 25) was more frequent than subcutaneous (n = 9). Most patients suffered from intractable partial epilepsy. After 6 months, 12 months, 24 months, and 36 months, 14/34 patients (41%), 16/34 patients (47%), 17/30 patients (57%) and 12/20 patients (60%) respectively were responders. Two patients (6%) became seizure-free. Complications related to implantation were minor: eight cases of limited cervical hypoesthesia, two minor scar infections and one Horner syndrome. Adverse events (voice hoarseness, throat paresthesia, coughing) related to stimulation were generally mild and tended to wane over time. However, a reduction in seizure frequency did not translate into a reduction in medication, as only 9% of responders had less antiepileptic medication at last follow-up compared to baseline.Conclusion:VNS as practiced at Notre-Dame hospital is an efficacious and safe treatment for refractory epilepsy. Quotas allotted to epilepsy centers in the province of Quebec should be lifted or increased to allow more patients to benefit from this therapeutic device.


2015 ◽  
Vol 29 (2) ◽  
pp. 151-160
Author(s):  
M.R. Gorgan ◽  
A. Giovani ◽  
F.M. Brehar

Abstract Vagus nerve stimulation (VNS) represents one of the main surgical options for the treatment of the refractory epilepsy in pediatric and adult patients. There are several mechanism involved in vagal nerve stimulation which could influence the pathophysiology of seizures like neuromodulation of the thalamic and subthalamic nuclei involved in seizure initiation and the modulation of the neurotransmitters pattern norepinefrin, GABA, and serotonin. The VNS system is composed of the implanted components (the generator, the lead with the electrodes attached) and the programming system components (programming wand and handheld computer). The authors present their experience with 81 patients diagnosed with refractory epilepsy, investigated, selected and implanted with vagal neurostimulators between December 2012 and January 2015 in Neurosurgery Clinic, "Bagdasar-Arseni" Emergency Hospital. The surgical technique and the potential pitfalls are described in detail. There were 20 children (24,7%) and 61 (75,3%) adults in this series. There was no death in this series and no intraoperative incidence. One patient presented dysphagia postoperatively which completely remitted after two months of follow-up. The outcome in term of seizure frequency and severity was better for patients under 30 years compared with patients older than 30 years. VNS represents now a safe, quick and efficient surgical procedure with a minimum period of hospitalization and a short recovery period. The good results on long term improve the quality of life of the patients and facilitate the social and professional reinsertion


Epilepsia ◽  
2009 ◽  
Vol 50 (5) ◽  
pp. 1220-1228 ◽  
Author(s):  
Amre Shahwan ◽  
Catherine Bailey ◽  
Wirginia Maxiner ◽  
A. Simon Harvey

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