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State of the field

Bioelectronic Medicine

Treating disease by stimulating peripheral nerves, especially the vagus nerve, instead of, or alongside, drugs.

Maturity
In the clinic

Overview reviewed

Where things stand

Bioelectronic medicine uses electrical stimulation of nerves to change how organs and the immune system behave. Some of it is established practice. Vagus nerve stimulation (VNS) has been FDA-approved for drug-resistant epilepsy since 1997 and for treatment-resistant depression since 2005, and paired VNS for upper-limb stroke rehabilitation was approved in 2021. Hypoglossal nerve stimulation for obstructive sleep apnea and sacral nerve stimulation for bladder and bowel control are also in routine use.

The inflammatory reflex

The field's newest wave rests on the "inflammatory reflex": work from Kevin Tracey's group showed that vagus nerve signalling suppresses pro-inflammatory cytokine release (Borovikova et al., Nature, 2000). A first-in-human study reported reduced rheumatoid arthritis disease activity with implanted VNS (Koopman et al., PNAS, 2016), leading to sham-controlled trials of implanted stimulators for rheumatoid arthritis and studies in inflammatory bowel disease.

What is contested

Effect sizes in autoimmune disease vary between studies, and the neural circuit (including the role of the spleen) is still being mapped. Non-invasive transcutaneous and cervical devices are attractive, but many published studies are small, open-label or retrospective. Readers should weigh sham-controlled randomized results above uncontrolled cohorts.

What to watch

Pivotal-trial readouts and regulatory decisions for autoimmune indications, fibre-selective stimulation, and closed-loop systems that adjust stimulation based on measured biomarkers.

Milestones

  1. 1958First fully implanted pacemaker. In Stockholm, Rune Elmqvist and Åke Senning implant the first fully internal cardiac pacemaker, a starting point for implantable bioelectronic medicine.
  2. 1997Vagus nerve stimulation approved for epilepsy. The US FDA approves vagus nerve stimulation for drug-resistant epilepsy, the first approved therapy built on stimulating a peripheral nerve to treat a brain disorder.
  3. 2000The inflammatory reflex. Kevin Tracey's group shows that stimulating the vagus nerve suppresses release of the inflammatory cytokine TNF. This links the nervous system to immune control and opens the way to electrical treatments for inflammatory disease.

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