Patients with dysphagia following acute anterior cerebral circulation or brainstem stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Subjects are randomised to receive either real or sham pharyngeal electrical stimulation at low frequency. The intensity of the electrical stimulation is determined following the calculation of suitab
Sponsors
Phagenesis Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The target population is patients with dysphagia following acute anterior cerebral circulation or brainstem stroke that meet all the inclusion and exclusion criteria and are considered eligible to be entered into this clinical investigation. Screening: 1. Subject is over 18 years of age 2. Subject is suspected of having dysphagia 3. Subject is able to comply with videofluoroscopy protocol 4. Subject diagnosed with stroke 5. Subject has no previous history of dysphagia 6. Subjects who are able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained/ or a consultee has consented on the subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves. 7. Subject is not currently participating in any other interventional clinical study 8. Subject is able to comply with clinical investigation plan requirements 9. Subject scores 0 or 1 on question 1a of the National Institute of Health Stroke Scale Randomisation: Subject has confirmed dysphagia (penetration-aspiration scores (PAS) of 3 or more during the videofluoroscopy (VFS) screening protocol)
Exclusion criteria
Exclusion criteria: 1. Subject stroke event was more than 42 days ago 2. Subject is pregnant or a nursing mother 3. Subject, in the opinion of the investigator, has advanced dementia 4. Subject fitted with a pacemaker or implantable cardiac defibrillator 5. Subject has unstable cardiopulmonary status 6. Subject has distorted oropharyngeal anatomy (e.g., pharyngeal pouch) 7. Subject is dysphagic from conditions other than stroke 8. Subject has been diagnosed with a progressive neurological disorder, such as Parkinson?s, Multiple Sclerosis 9. Subject has a chronic medical condition that compromises cardiac or respiratory status (e.g. severe emphysema or heart failure that may render the insertion of the throat unsafe) 10. Subject is receiving continuous oxygen treatment or the equipment for this is in place
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean penetration-aspiration scores (PAS) on videofluoroscopy (VFS) post-treatment between (real and sham) treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this clinical investigation are (all will be compared to the placebo group excl. ease of use): 1. Incidence of all of adverse events 2. Change in Penetration-aspiration scores at 12-week assessment 3. Change in SALT management plan 4. Change in Dysphagia Severity Rating Scale (DSRS) at 2-week, and 12-week assessments 5. Change in NIHSS at 2, and 12-week assessments (see appendix F) 6. Change in mRS and BI at 2, 6 and 12-week assessments (see appendix D&E) 7. Frequency of chest infection up to discharge or 12-week follow up (whichever is sooner) 8. Time from randomisation to death (within 12-week follow-up) 9. Time from randomisation to removal of NG or PEG tube in relevant sub-stratum 10. Feeding status as 2, 6 and 12 weeks 11. Weight at 2 and 12 week assessments 12. BMI at 2 and 12 week assessments 13. Mid arm circumference at 2 and 12 weeks 14. Albumin at 2 and 12 week assessment 15. Discharge destination 16. Ease of use of the device by way of questionnaire to HCPs delivering (real or sham) treatment. 17. Quality of Life by means of EQ5D 18. To evaluate relationship between personality type and functional recovery | — |
Countries
United Kingdom
Outcome results
None listed