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Therapeutic application of neuro-stimulation in acute dysphagic stroke

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83103698
Enrollment
80
Registered
2003-01-07
Start date
2005-11-08
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute dysphagic stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

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 determ

Sponsors

University of Manchester (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026