AHE02 - PHADER
Research type
Research Study
Full title
A prospective single-arm, observational clinical follow-up study on the application of PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia: a European Registry (PHADER).
IRAS ID
168114
Contact name
Jaak Minten
Contact email
ISRCTN Number
ISRCTN87110165
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Patients suffering from a variety of conditions such as Stroke, Parkinson’s Disease or artificial ventilation typically experience difficulty with swallowing known as ‘neurogenic dysphagia’. A common consequence of difficult swallowing is that food or drinks end-up in the lungs where they can cause serious chest infections. All of this can make recovery from difficult swallowing more cumbersome and often, alternative feeding methods are proposed as a therapy. 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 medical device (Phagenyx) which is designed to be used by health professionals on a routine basis at the bedside.
Previous research on the Phagenyx treatment shows that it can help improve swallowing function. This research has mainly been performed in Stroke patients but other causes of ‘neurogenic dysphagia’ can also be treated by the device and may benefit from treatment. This Registry, will document the regular use of the Phagenyx treatment devices in the ‘real world’ by observing how the devices work and documenting the potential benefit (or lack of benefit) of the treatment in patients suffering from a variety of conditions that have caused swallowing difficulty than has been done so far. The study does not require any specific medical procedures to be conducted, other than those that are normally offered to patients with swallowing difficulties as standard treatment.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0047
Date of REC Opinion
22 Apr 2015
REC opinion
Further Information Favourable Opinion