Trial reportNeuromodulation : journal of the International Neuromodulation Society2016
Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia: Clinical Outcomes and Device Performance--The U.S. E-37 Trial.
Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01846741 (VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia), which is not on this map. Cited by 53 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia
Who cites it
53 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Vagus nerve stimulation for focal seizures.The Cochrane database of systematic reviews · 2022Pooled it
- Neurocardiology: Brain-Heart Interactions in the Heart.MedComm · 2026Review
- A guide to neuromodulation in drug-resistant epilepsy.Epileptic disorders : international epilepsy journal with videotape · 2026Review
- Review
- A structured narrative review on VNS-treated drug-resistant epilepsy: EEG markers, neurochemical mechanisms, and future biomarker-driven computational directions.Frontiers in neuroscience · 2026Review
- Autonomic biosignals, seizure detection, and forecasting.Epilepsia · 2025Review
- Reduction of generalized tonic-clonic seizures following vagus nerve stimulation therapy: CORE-VNS Study 24-month follow-up.Epilepsia · 2025Observational
- A Novel Closed-Loop Electrical Brain Stimulation Device Featuring Wireless Low-Energy Ultrasound Power and Communication.Neuromodulation : journal of the International Neuromodulation Society · 2025Article
- Seizure Detection Devices.Journal of clinical medicine · 2025Review
- Home-Based sensing of the nervous system with clinical neurophysiology technologies: IFCN handbook chapter.Clinical neurophysiology practice · 2025Review
- Applications of Endovascular Brain-Computer Interface in Patients with Alzheimer's Disease.Research (Washington, D.C.) · 2025Review
- Vagus nerve stimulation for epilepsy: A narrative review of factors predictive of response.Epilepsia · 2024Review
- Harnessing the sensing and stimulation function of deep brain-machine interfaces: a new dawn for overcoming substance use disorders.Translational psychiatry · 2024Review
- Review
- Closed-loop neurostimulation for the treatment of psychiatric disorders.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024Review
- A narrative review of vagus nerve stimulation in stroke.Journal of central nervous system disease · 2024Review
- Article
- Exercise in patients with epilepsy and neurostimulation devices - physical activity levels, barriers, and beliefs.Epilepsy & behavior reports · 2024Article
- Vagus nerve electroneurogram-based detection of acute kainic acid induced seizures.Frontiers in neuroscience · 2024Article
- Complete Heart Block and Ventricular Asystole Caused by Vagus Nerve Stimulation Therapy.Cureus · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe Automatic Stimulation Mode (AutoStim) feature of the Model 106 Vagus Nerve Stimulation (VNS) Therapy System stimulates the left vagus nerve on detecting tachycardia. This study evaluates performance, safety of the AutoStim feature during a 3-5-day Epilepsy Monitoring Unit (EMU) stay and long- term clinical outcomes of the device stimulating in all modes. MATERIALS AND
methodsThe E-37 protocol (NCT01846741) was a prospective, unblinded, U.S. multisite study of the AspireSR(®) in subjects with drug-resistant partial onset seizures and history of ictal tachycardia. VNS Normal and Magnet Modes stimulation were present at all times except during the EMU stay. Outpatient visits at 3, 6, and 12 months tracked seizure frequency, severity, quality of life, and adverse events.
resultsTwenty implanted subjects (ages 21-69) experienced 89 seizures in the EMU. 28/38 (73.7%) of complex partial and secondarily generalized seizures exhibited ≥20% increase in heart rate change. 31/89 (34.8%) of seizures were treated by Automatic Stimulation on detection; 19/31 (61.3%) seizures ended during the stimulation with a median time from stimulation onset to seizure end of 35 sec. Mean duty cycle at six-months increased from 11% to 16%. At 12 months, quality of life and seizure severity scores improved, and responder rate was 50%. Common adverse events were dysphonia (n = 7), convulsion (n = 6), and oropharyngeal pain (n = 3).
conclusionsThe Model 106 performed as intended in the study population, was well tolerated and associated with clinical improvement from baseline. The study design did not allow determination of which factors were responsible for improvements.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.