1.1 Evidence on the safety of implanted vagus nerve stimulation for treatment-resistant depression raises no major safety concerns, but there are frequent, well-recognised side effects. Evidence on its efficacy is limited in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE website.
1.2 Clinicians wishing to do implanted vagus nerve stimulation for treatment-resistant depression should:
Inform the clinical governance leads in their NHS trusts.
Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these.
Audit and review clinical outcomes of all patients having the procedure. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion).
1.3 NICE encourages further research into implanted vagus nerve stimulation for treatment-resistant depression, in the form of randomised controlled trials with a placebo or sham stimulation arm. Studies should report details of patient selection. Outcomes should include validated depression rating scales, patient-reported quality of life, time to onset of effect and duration of effect, and any changes in concurrent treatments.