Therapeutic application of neuro-stimulation in acute dysphagic stroke

ISRCTN	ISRCTN83103698
DOI	https://doi.org/10.1186/ISRCTN83103698
Protocol serial number	G108/374
Sponsor	University of Manchester (UK)
Funder	National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)

Submission date: 07/01/2003
Registration date: 07/01/2003
Last edited: 03/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S Hamdy
Scientific

GI Sciences
Hope Hospital
Eccles Old Road
Salford
M6 8HD
United Kingdom

Phone	+44 (0)161 787 4414
Email	Shaheen.hamdy@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of pharyngeal electrical stimulation in the treatment of dysphagia after brain injury
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	08/11/2005
Date of final enrolment	30/11/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

GI Sciences

Salford
M6 8HD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	abstract from Annual Meeting of the American Gastroenterological Association/Digestive Disease Week:	01/04/2005		No	No
Abstract results	abstract from Annual Meeting of the British Society of Gastroenterology:	01/04/2006		No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes