AHE-05 - PhEED

• Research type

  Research Study

• Full title

  Pharyngeal Electrical Stimulation Evaluation for Dysphagia after Stroke (PhEED)

• IRAS ID

  243033

• Contact name

  Nadine Juran

• Contact email

  nadine.juran@phagenesis.com

• Sponsor organisation

  Phagenesis

• Clinicaltrials.gov Identifier

  NCT03358810

• Duration of Study in the UK

  2 years, 3 months, 16 days

• Research summary

  Research Summary
  Neurogenic oropharayngeal dysphagia (difficulty with swallowing) is common in the post-stroke setting. A common consequence of difficult swallowing is that food or drinks end up in the lungs that can cause serious chest infections. As a result it is associated with increased incidence of in-hospital pneumonia, worse outcome and greater resource utilisation.
  To treat the symptoms of difficult swallowing, patients are often given special training or swallowing techniques to use but these are not always effective and many patients end up needing long term feeding through a tube surgically placed in their stomach.
  Alternative treatments are now available. One such treatment named 'Pharyngeal Electrical Stimulation' (PES), is a simple and harmless technique for treating difficult swallowing. PES treatment is delivered using a commercially available (CE Marked) medical device (Phagenyx) which is designed to be used by health professionals on a routine basis at the bedside.
  This study will test the safety and performance of the Phagenesis Phagenyx System to improve recovery of swallowing

  This study is designed to support a new submission for a non-significant risk device in the United States.

  Summary of Results
  Swallowing difficulty (neurogenic dysphagia) is a severely debilitating condition that has no definitive treatment. It is commonly observed in conditions such as stroke and traumatic brain injury and is significantly associated with poor health outcomes in patients. Pharyngeal electrical stimulation (PES) is a potential treatment for neurogenic dysphagia. The Phagenyx® system, a medical device developed by Phagenesis Ltd. (Manchester, UK) for PES, received approval (CE labelling) in 2012 for the treatment of neurogenic dysphagia in adults and is commercially available across Europe. The treatment involves delivering short bursts of electrical current to the back of the throat for 10 minutes a day for 3-6 days. Research studies show that PES can help restore the neurological control mechanisms responsible for safe swallowing in patients with neurogenic dysphagia.

  The Pharyngeal Electrical Stimulation Evaluation for Dysphagia after Stroke (PhEED) study was designed as a randomized, sham-controlled, patient-masked, outcome assessor-blinded, multi-centre study to assess PES for the treatment of swallowing difficulties following a stroke. The study was conducted in 11 hospitals across the United Kingdom, United States and Europe (Finland and Germany). However, over an 18-month period, only 17 patients were enrolled, largely because of a high (66%) screen failure rate attributed to the study’s strict eligibility criteria. Due to the difficulties in recruitment, the Sponsor and Trial Steering Committee decided to stop the study in July 2020. However, despite the challenges, the study data collected in the 17 patients showed that PES was safe and that patients treated with PES appeared to show some benefit through a greater advancement toward a normal diet as evidenced by improved dysphagia severity rating scales and functional oral intake scale scores. These findings continue to provide support for the use of PES in patients with swallowing difficulties (neurogenic dysphagia) caused by stroke.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  18/NW/0263

• Date of REC Opinion

  8 Jun 2018

• REC opinion

  Further Information Favourable Opinion