Table 2.
Clinical trials investigating the effects of vagal neuromodulation on inflammation. – indicates value unspecified; n refers to intervention/control. AF, atrial fibrillation; CABG, coronary artery bypass grafting; LVEDV, left ventricular end diastolic volume; LVEF, left ventricular ejection fraction; LVESV, left ventricular end systolic volume; PCI, percutaneous coronary intervention; PMID, PubMed Identification Number; STEMI, ST elevation myocardial infarction; taVNS, transcutaneous auricular vagus nerve stimulation; tcVNS, transcutaneous cervical vagus nerve stimulation; VNS, vagus nerve stimulation.
| Authors, ref. no., year (PMID) | Study design | Subjects (n) | Age (yr) | Sex (% female) | Intervention | Start of intervention | Stimulation parameters |
Control | Outcome measured | Outcome time point | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| On/off period (s) | Duration (min) | Pulse width (μs) | Pulse frequency (Hz) | Intensity (mA) | ||||||||||
| Stakenborg and colleagues,48 2019 (30472681) | RCT | Surgical (10/10) | 60–68 | 70 | Abdominal VNS | 16 and 2 h preoperatively | – | 20 | 1000 | 20 | 2.5 | Sham or no (combined control arm) | IL-6 and IL-8 (pg ml−1) | 24, 48 h |
| Stavrakis and colleagues,49 2017 (29759717) | RCT | Surgical (26/28) | 43–72 | 29.6 | Transvenous VNS | On arrival in ICU (time point unspecified) | – | 4320 | 1000 | 20 | – | Sham | TNF-α, IL-6 and IL-10 (pg ml−1), CRP (mg L−1) | 24, 72 h |
| Kox and colleagues,26 2015 (26049730) | RCT | Volunteer (10/10) | 23–27 | 0 | Transvenous VNS | 10 min before intravenous administration of E. coli LPS | – | 30 | 1000 | 20 | 2–10 V | Sham | TNF-α, IL-6, IL-8 and IL-10 (pg ml−1) | 48 h |
| Stavrakis and colleagues,50 2015 (25744003) | RCT | Paroxysmal AF needing ablation (20/20) | 53–69 | 35 | taVNS | Pre-induction of general anaesthesia (time point unspecified) | – | 60 | 1000 | 20 | – | Sham | TNF-α, IL-6 and IL-10 (pg ml−1), CRP (mg L−1) | 20 min |
| Salama and colleagues,51 2020 (32358638) | RCT | Surgical (50/50) | 54–72 | 50 | taVNS | 24 h preoperatively | – | 40 | 200 | – | 0.23 | Sham | TNF-α, IL-6, IL-1β and IL-10 (pg ml−1), CRP (mg L−1) | 24, 96 h |
| Yu and colleagues,52 2017 (28797427) | RCT | STEMI needing PCI (47/48) | 18–80 | 25.3 | taVNS | 35 min before reperfusion in catheterisation laboratory | 5 | 155 | 1000 | 20 | – | Sham | IL-6 and TNF-α (ng L−1), IL-1β (pg L−1), high-mobility group-box 1 protein (ng ml−1) | 72 h |