A multi-centre, double blind, randomised controlled clinical investigation to validate the EPS1 device as a treatment for stroke-induced dysphagia: a study of Swallowing Treatment using Electrical Pharyngeal Stimulation (STEPS study)

Phagenesis Ltd (UK)0 个研究点目标入组 140 人开始时间: 2012年7月19日最近更新: 2016年10月17日

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•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.
•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)

•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

发起方

Phagenesis Ltd (UK)