Condition category
Circulatory System
Date applied
19/04/2012
Date assigned
19/07/2012
Last edited
12/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Swallowing food and drink is part of our daily life and something that we do automatically. Sometimes people who suffer a stroke will have difficulties with swallowing which complicates their recovery. Food and drink may go down the wrong way and end up in the lungs, and this can cause chest infections. Patients with swallowing problems may be advised by the medical team to be ‘nil by mouth’ or to only consume drinks that are thickened and food that is blended. Such advice is intended to help patients swallow more easily and safely in an attempt to reduce the risk of developing a chest infection. However, current methods of treating swallowing problems after a stroke are often not effective as some patients end up needing long-term feeding via a tube inserted into the stomach. This study aims to find out if electrical stimulation of the brain through stimulating nerves in the throat using a specially made tube (catheter) can speed up the recovery of safe swallowing in stroke patients.

Who can participate?
Patients aged 18 or older admitted to one of the participating hospitals following a stroke and diagnosed with dysphagia (swallowing problems).

What does the study involve?
Participants have a thin tube placed into the back of their throat at their bedside and are randomly allocated to receive either real (active) or sham (placebo) electrical pharyngeal stimulation treatment for three days. Swallowing is measured using a special X-ray examination called a Videofluoroscopy. This examination allows the amount of liquid entering the lungs to be assessed. At 2 and 12 weeks after the treatment has finished, a repeat swallow X-ray and a bedside assessment are carried out to look for any improvements in swallowing function. The research treatment is an ‘add on’ to the standard clinical care that patients continue to receive on the ward.

What are the possible benefits and risks of participating?
Patients allocated to placebo treatment may not get any benefit. Patients in the active treatment group may experience a reduction in harmful swallows and may be more likely to return to normal eating. The insertion of the stimulation tube through the nose can produce mild but temporary irritation of the nose or throat. Videofluoroscopy involves exposure to a low dose of radiation.

Where is the study run from?
The research trial will only take place in the participating hospitals.

When is the study starting and how long is it expected to run for?
April 2012 to December 2012

Who is funding the study?
Phagenesis Ltd (UK)

Who is the main contact?
Mrs Joanna Love
jo.love@phagenesis.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Joanna Love

ORCID ID

Contact details

Phagenesis Ltd
Enterprise House
Pencroft Way
Manchester Science Park
Manchester
M15 6SE
United Kingdom
+44 (0)161 820 4525
jo.love@phagenesis.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AHE01

Study information

Scientific title

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)

Acronym

STEPS

Study hypothesis

The Electrical Pharyngeal Stimulation 1 (EPS1) device improves swallowing function and reduces dysphagia-associated complications in stroke dysphagic patients.

Ethics approval

East of England - Essex, 06/02/2012, ref: 12EE/0005

Study design

Multi-centre prospective randomised controlled two-arm double-blind clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients with dysphagia following acute anterior cerebral circulation or brainstem stroke

Intervention

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 suitable sensory threshold, tailored to the individual participants. Subjects receive the intervention 3 times in a week, within a few days following index videofluoroscopy.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

05/04/2012

Overall trial end date

23/12/2012

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant 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

Recruitment start date

05/04/2012

Recruitment end date

23/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Phagenesis Ltd
Manchester
M15 6SE
United Kingdom

Sponsor information

Organisation

Phagenesis Ltd (UK)

Sponsor details

c/o Mrs Joanna Love
Enterprise House
Pencroft Way
Manchester Science Park
Manchester
M15 6SE
United Kingdom
+44 (0)161 820 4525
jo.love@phagenesis.com

Sponsor type

Industry

Website

http://www.phagenesis.com

Funders

Funder type

Industry

Funder name

Phagenesis Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27165955

Publication citations

Additional files

Editorial Notes

12/05/2016: Publication reference added. 02/03/2016: No publications found, verifying study status with principal investigator