Swallowing treatment using electrical pharyngeal stimulation: a treatment of the throat for swallowing problems after stroke

Completed

• Conditions: Patients with dysphagia following acute anterior cerebral circulation or brainstem stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN25681641
• Lead Sponsor: Phagenesis Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean penetration-aspiration scores (PAS) on videofluoroscopy (VFS) post-treatment between (real and sham) treatment groups.