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Swallowing Treatment using Electrical Pharyngeal Stimulation (STEPS Study): A treatment of the throat for swallowing problems after stroke
ISRCTN ISRCTN25681641
DOI 10.1186/ISRCTN25681641
ClinicalTrials.gov identifier
EudraCT number
Public title Swallowing Treatment using Electrical Pharyngeal Stimulation (STEPS Study): A treatment of the throat for swallowing problems after stroke
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
Serial number at source AHE01
Study hypothesis The Electrical Pharyngeal Stimulation 1 (EPS1) device improves swallowing function and reduces dysphagia-associated complications in stroke dysphagic patients.
Lay 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 in order to achieve the following:
1. Reduced risk of food and drink spilling into the lungs (termed ‘aspiration’)
2. Reduced risk of getting chest infections due to aspiration
3. Return normal and safe swallowing as early as possible

Who can participate?
Patients admitted to one of the participating hospitals following a stroke (classified as either acute anterior cerebral circulation or brainstem) and are diagnosed with dysphagia (swallowing problems).

Patients must also be/have:
1. Aged 18 years or older
2. Dysphagia
3. Able to have videofluoroscopy (swallow X-ray) assessments
4. Diagnosed with stroke within the last 5 weeks
5. No previous history of dysphagia
6. Able to communicate, but this does not have to be by talking

What does the study involve?
Testing how effective the device is at improving swallowing ability in stroke patients with swallowing problems. Swallowing will be measured using a special X-ray examination called a Videofluoroscopy. This examination allows the amount of liquid entering the lungs to be assessed. These scores will be compared between two equal groups of patients which will be randomly allocated by a computer program:
Group one (70 patients) = Real treatment
Group two (70 patients) = Sham (placebo) treatment
In order to ensure that both groups of patients are treated the same without either group getting an unfair advantage over the other, the researchers will not inform patients or the medical team as to which treatment group a patient belongs to either before or during the research study.
All the patients in the study (both groups) will have a thin tube placed into the back of their throat at their bedside and will receive the electrical pharyngeal stimulation treatment (real or sham) for three days. At 2 and 12 weeks after the treatment has finished, a repeat swallow X-ray and a bedside assessment will be carried out to look for any improvements in swallowing function. The research treatment is an ‘add on’ to the standard clinical care that patients will continue to receive on the ward.

What are the possible benefits and risks of participating?
As the study is placebo controlled, some patients may not get any benefit. In the active arm they
may have a reduction in harmful swallows and are more likely to return to normal eating.
Swallow X-Ray (Videofluoroscopy):
Exposure to a low dose radiation during the swallow X-ray tests is possible risk.
Insertion of tube into throat:
The insertion of the stimulation tube through the nose can produce mild but temporary irritation of the nose or throat.

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

When is study starting and how long is it expected to run for?
The study will take place during the day in the first five weeks after the patient’s stroke. After this, patients will be asked to return to the hospital 2 and 12 weeks after finishing the treatment for repeat swallow X-ray tests.

Who is funding the study?
Phagenesis Limited, UK

Who is the main contact?
Mrs Joanna Love
jo.love@phagenesis.com
Ethics approval East of England - Essex, 06 February 2012, ref: 12EE/0005
Study design Multi-centre prospective randomised controlled two-arm double blind clinical study
Countries of recruitment United Kingdom
Disease/condition/study domain Patients with dysphagia following acute anterior cerebral circulation or brainstem stroke
Participants - 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)
Participants - 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
Anticipated start date 05/04/2012
Anticipated end date 23/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 140
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 suitable sensory threshold, tailored to the individual participants. Subjects receive the intervention 3 times in a week, within a few days following index videofluoroscopy.
Primary outcome measure(s) Change in mean penetration-aspiration scores (PAS) on videofluoroscopy (VFS) post-treatment between (real and sham) treatment groups.
Secondary outcome measure(s) 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
Sources of funding Phagenesis Limited (UK)
Trial website
Publications
Contact name Mrs  Joanna  Love
  Address Phagenesis Ltd
Enterprise House
Pencroft Way
Manchester Science Park
  City/town Manchester
  Zip/Postcode M15 6SE
  Country United Kingdom
  Tel +44(0)161 820 4525
  Email jo.love@phagenesis.com
Sponsor Phagenesis Ltd (UK)
  Address c/o Mrs Joanna Love
Enterprise House
Pencroft Way
Manchester Science Park
  City/town Manchester
  Zip/Postcode M15 6SE
  Country United Kingdom
  Tel +44 (0)161 820 4525
  Email jo.love@phagenesis.com
  Sponsor website: http://www.phagenesis.com
Date applied 19/04/2012
Last edited 19/07/2012
Date ISRCTN assigned 19/07/2012
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