We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Gemma
Squires
+44 (0)82 31255
Gemma.Squires1@nottingham.ac.uk
Mr
Philip
Bath
+44 (0)115 82 31768
philip.bath@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Post-stroke dysphagia
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Acute stroke is common and complicated by dysphagia (swallowing problems) in over 50% of patients, many of whom remain dysphagic a year later. Post-stroke dysphagia (PSD) is an independent predictor of poor outcome and can lead to aspiration of material into the lungs, pneumonia, malnutrition and death. Patients often need feeding through a tube, have a prolonged hospital stay, and end up in long-term institutional care. PSD negatively impacts quality of life and its care is expensive and may be a tipping point for admission to residential care. Pharyngeal electrical stimulation (PES) is electrical stimulation of certain areas of the throat that stimulates the areas of the brain involved in swallowing. This study aims to find out whether PES is safe and effective at improving post-stroke dysphagia.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 14/11/2023:
1. Hospitalised adults (age ≥18 years)
2. Recent (4-31 days) ischaemic or haemorrhagic anterior or posterior circulation stroke (as diagnosed clinico-radiologically) at a comprehensive or primary care stroke centre
3. Clinical dysphagia defined as a functional oral intake scale score of 1 (nothing by mouth, feeding by nasogastric tube [NGT]/percutaneous endoscopic gastrostomy [PEG] tube), 2 (tube dependent with minimal attempts of food or liquids) or 3 (tube dependent with consistent oral intake of food or liquids)
4. NIHSS item 1a score of 0, 1 or 2 (where the patient requires repeated stimulation to arou
You may not be able to take part if:
Current exclusion criteria as of 14/11/2023:1. Non-stroke dysphagia, e.g. due to traumatic brain haemorrhage, subarachnoid haemorrhage, brain tumour, Parkinson’s disease, multiple sclerosis, severe dementia, head or neck cancer2. Pre-stroke dysphagia or dependency (modified Rankin scale, mRS 4/5)3. NIHSS item 1a score of 2 (where the patient only responds to pain) or NIHSS item 1a score of 34. Ongoing or anticipated ventilation/intubation/tracheostomy5. Ongoing treatment of dysphagia with other forms of electrical / magnetic stimulation e.g. NMES, TCDS, rTMS6. Malignant middle cerebral artery syndrome (although this typically presents before 4 days)7. Pacemaker, cochlear implant or implantable cardioverter-defibrillator8. Need for >35% of oxygen9. Patient expected to be repatriated to a separate organisation10. Patient expected to be rehabilitated at a separate organisation11. Patient not likely to be in the treating hospital for at least 14 days12. Two or more NGT tubes pulled out unless nasal bridle in place13. Investigator feels patient will not tolerate PES catheter14. Expected to be discharged or transferred to a site not running the trial during the PES treatment period15. Pregnancy if known at time of enrolment16. Participating in another randomised controlled treatment trial for post-stroke dysphagia17. Palliative care
_____
Previous exclusion criteria:1. Non-stroke dysphagia, e.g., due to traumatic brain haemorrhage, subarachnoid haemorrhage, brain tumour, Parkinson’s disease, multiple sclerosis, severe dementia, head or neck cancer2. Pre-stroke dysphagia or dependency (modified Rankin scale [mRS] 4/5)3. Ongoing or anticipated ventilation/intubation/tracheostomy or use of electrical or magnetic stimulation4. Malignant middle cerebral artery syndrome5. Pregnant6. Pacemaker7. Need for >2 litres of oxygen8. Two or more NGT pulled out unless nasal bridle in place9. Investigator feels the patient will not tolerate PES catheter
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Gemma
Squires
+44 (0)82 31255
Gemma.Squires1@nottingham.ac.uk
Mr
Philip
Bath
+44 (0)115 82 31768
philip.bath@nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Nottingham and funded by Health Technology Assessment Programme; Phagenesis Ltd.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 50913
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
