- Swallowing difficulties after stroke or brain injury are common and affect millions of people worldwide.
- We showed that electrical stimulation of the pharynx in the throat improves swallowing.
- Our stimulation device Phagenyx is used across Europe and recently approved in the US.
Dysphagia is common, harmful and costly
Many people who have suffered a stroke or other brain injury are left with difficulty or an inability to swallow safely, due to damage to areas of the brain that control swallowing. Known as neurogenic dysphagia, it affects millions of people worldwide. It is also common in patients who have had a tracheotomy (incision in the windpipe).
It means these patients often need to be fed through a tube, and their quality of life is dramatically reduced. It also delays their recovery, increasing the time they spend in hospital.
Targeting the root cause of dysphagia
Research from The University of Manchester and the University spin-out company Phagenesis Ltd discovered that electrical stimulation of the pharynx (an area of the throat) could stimulate areas of the brain involved in swallowing and improve the ability to swallow.
Using this knowledge, the team developed a device called Phagenyx that uses pharyngeal electrical stimulation (PES) to treat the cause of dysphagia.
Prof Shaheen Hamdy
Shaheen is a Professor in Medicine (Gastroenterology) at The University of Manchester and delivers clinical care at Salford Royal Hospital NHS Trust.
Non-surgical therapy restores swallowing control and speeds up recovery
In multiple clinical trials, the team showed that PES using Phagenyx significantly improved swallowing, firstly in stroke patients in 2018 (the PHAST-TRAC trial) then in other neurological disorders or brain injuries in 2020 (the PHADER trial).
The PHADER study found that treatment with Phagenyx helped restore neurological control of swallowing, meaning that patients could swallow more safely, eat more varied foods, have feeding tubes removed and be discharged from hospital earlier.
Helping patients in UK and Europe
The Phagenyx device is now commercially available and in use throughout the UK and Europe, benefiting thousands of people living with swallowing difficulties. In April 2021, scientists in Austria reported successful use of Phagenyx PES treatment to restore safe swallowing in a patient critically ill with COVID-19.
In April 2023, the Royal College of Physicians updated their National Clinical Guideline for Stroke for the UK and Ireland, recommending that PES may be considered for patients with tracheostomy and severe dysphagia after stroke to aid decannulation (removal of tracheostomy tube). This recommendation was based on the PHAST-TRAC trial.
Product launch in the US
In 2022, the US Food and Drug Administration (FDA) approved the use of Phagenyx to restore swallowing control in patients with severe dysphagia following stroke. A targeted launch in the US is underway, and several US hospitals are now evaluating the therapy.
In May 2023, Gaylord Specialty Healthcare, a rehabilitation-focused, non-profit healthcare provider, was the first in the US to adopt the technology.
Peter Grevelding, Gaylord Specialty Healthcare Vice President of Clinical Operations and Executive Director, said: "We have seen great results with the very first patients. It will be a valuable tool in improving the quality of care for our stroke patients who face swallowing problems."
- The cortical topography of human swallowing musculature in health and disease
First to map the swallow motor cortex in health and disease.
- Recovery of swallowing after dysphagic stroke relates to functional reorganization in the intact motor cortex
First to show that dysphagia recovery is due to functional reorganisation of the swallow motor cortex.
- Long-term reorganization of human motor cortex driven by short-term sensory stimulation
First to show that long-term reorganisation of the cortex can be driven by short-term sensory stimulation.
- Driving plasticity in human adult motor cortex is associated with improved motor function after brain injury
First to show that sensory stimulation driven reorganisation results in functional swallow recovery.
- PHAryngeal electrical STimulation for early decannulation in TRACheotomised stroke patients with neurogenic dysphagia (PHAST-TRAC): a prospective randomised single-blinded trial
- Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: main results from the PHADER cohort study
In patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration.
- Review shows neurostimulation is promising dysphagia treatment (University of Manchester)
- Phagenesis launches Phagenyx neurostimulation system in the US (University of Manchester Innovation Factory)