Condition category
Circulatory System
Date applied
07/01/2003
Date assigned
07/01/2003
Last edited
03/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Hamdy

ORCID ID

Contact details

GI Sciences
Hope Hospital
Eccles Old Road
Salford
M6 8HD
United Kingdom
+44 (0)161 787 4414
Shaheen.hamdy@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G108/374

Study information

Scientific title

A randomised controlled trial of pharyngeal electrical stimulation in the treatment of dysphagia after brain injury

Acronym

Study hypothesis

Establish efficacy of pharyngeal stimulation in accelerating swallowing recovery after acute dysphagic stroke.

On 22/07/2008 the following changes were made to the trial record:
1. The anticipated start date was changed from 01/09/2003 to 08/11/2005.
2. The anticipated end date was changed from 31/08/2005 to 31/11/2013.
3. The sources of funding field was changed from 'Medical Research Council (UK) and The Health Foundation (UK) (ref: 1727/1793)' to 'Action Medical Research (UK) (until April 2009) and National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)'.

On 15/10/2009 the following changes were made to the trial record:
1. The scientific title was added.
2. The sources of funding field was changed from 'Action Medical Research (UK) (until April 2009) and National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) ' to 'National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)'.

Ethics approval

Salford and Trafford Research Ethics Committee, 01/10/2002, ref: 00167. An ethics amendment for the current phase of the study was approved on 08/11/2005.

Study design

Randomised controlled trial

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

Acute dysphagic stroke

Intervention

Current interventions as of 05/09/2008:
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 three times in a week, within a few days following index videofluoroscopy.

Previous interventions:
Real versus sham stimulation

The previous sponsor for this trial (from 01/09/2005 to 31/01/2008) was:
Medical Research Council (UK)
20 Park Crescent
London
W1B 1AL
United Kingdom

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 05/09/2008:
Penetration-aspiration score and swallowing response time, assessed by videofluoroscopy at baseline and 2 weeks after the intervention.

Previous primary outcome measures:
1. Mortality
2. Aspiration pneumonia
3. Swallowing function assessed by videofluoroscopy

Secondary outcome measures

Added as of 05/09/2008:
1. Aspiration pneumonia rates
2. Usage of antibiotics for chest infections
3. Hospital stays
4. Readmission rates
5. Mortality

Total duration of follow-up: 6 months

Overall trial start date

08/11/2005

Overall trial end date

30/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 05/09/2008:
Any patient with first event of an anterior circulation stroke (both males and females, no age limits). Patients are recruited within 3 weeks of their admission with stroke. Videofluoroscopy is carried out to determine the degree of airway penetration/aspiration.

Previous inclusion criteria:
Hemispheric stroke and dysphagia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Inability to give informed consent
2. Serious inter-current illness
3. Major neuromuscular modulating drugs
4. Other neurological diseases
5. Previous dysphagia

Recruitment start date

08/11/2005

Recruitment end date

30/11/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

GI Sciences
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

University Research Office
2nd Floor Chrisie Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)

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

1. 2005 abstract from Annual Meeting of the American Gastroenterological Association/Digestive Disease Week: http://www.ncbi.nlm.nih.gov/pubmed/15900640
2. 2006 abstract from Annual Meeting of the British Society of Gastroenterology: http://www.ncbi.nlm.nih.gov/pubmed/16531518

Publication citations

  1. Abstract from Annual Meeting of the British Society of Gastroenterology

    British Society of Gastroenterology Annual Meeting, 20-23 March 2006, Birmingham, England, United Kingdom. Abstracts., Gut, 2006, 55 Suppl 2, A1-119.

  2. Digestive Disease Week and the 106th Annual Meeting of the American Gastroenterological Association. May 14-19, 2005, Chicago, Illinois, USA. Abstracts., Gastroenterology, 2005, 128, 4 Suppl 2, A1-821.

Additional files

Editorial Notes