Swallowing treatment using electrical pharyngeal stimulation: a treatment of the throat for swallowing problems after stroke
| ISRCTN | ISRCTN25681641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25681641 |
| Secondary identifying numbers | AHE01 |
- Submission date
- 19/04/2012
- Registration date
- 19/07/2012
- Last edited
- 12/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Scientific
Phagenesis Ltd
Enterprise House
Pencroft Way
Manchester Science Park
Manchester
M15 6SE
United Kingdom
| Phone | +44 (0)161 820 4525 |
|---|---|
| jo.love@phagenesis.com |
Study information
| Study design | Multi-centre prospective randomised controlled two-arm double-blind clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| 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(s) | East of England - Essex, 06/02/2012, ref: 12EE/0005 |
| 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 |
| Primary outcome measure | 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 study start date | 05/04/2012 |
| Overall study end date | 23/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 |
| 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 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 Parkinsons, 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
- England
- United Kingdom
Study participating centre
M15 6SE
United Kingdom
Sponsor information
Industry
c/o Mrs Joanna Love
Enterprise House
Pencroft Way
Manchester Science Park
Manchester
M15 6SE
United Kingdom
| Phone | +44 (0)161 820 4525 |
|---|---|
| jo.love@phagenesis.com | |
| Website | http://www.phagenesis.com |
"ROR" |
https://ror.org/04a6evj08 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2016 | Yes | No |
Editorial Notes
12/05/2016: Publication reference added.
02/03/2016: No publications found, verifying study status with principal investigator
