Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients (EETI-01)

This study has been completed.
Sponsor:
Collaborator:
Centro de Investigación Biomédica en Red
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró
ClinicalTrials.gov Identifier:
NCT01363973
First received: May 27, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke. Despite its enormous impact on functional capacity, quality of life, and survival, OD is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. A recent systematic review on the effects of rehabilitation therapy on OD concluded that although some positive effects were found, the number of studies was small, many of them had methodological problems and there was a need for further research using randomized controlled trials. Transcutaneous electrical stimulation was approved by the FDA as a treatment of dysphagia in June 2001 and is traditionally used to activate pharyngeal muscles through stimulation of peripheral motor nerves (neuromuscular electrical estimulation, NMES). However, their real effectiveness and safety in the treatment of dysphagia is still matter of discussion (Logemann Dysphagia 2007, Ludlow dysphagia 2007) and studies evaluating NMES therapy, present discordant results. On the other hand, in recent years, transcutaneous electrical stimulation is beginning to use as a sensory strategy (Gallas 2010), avoiding muscle contraction during the treatment.Our research strategy includes the assessment of the therapeutic effect of these two main strategies using transcutaneous electrical stimulation on swallow physiology and clinical outcomes of post-stroke dysphagic patients.


Condition Intervention
Dysphagia
Device: VITALSTIM transcutaneous electrical stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Efficacy and Safety of Transcutaneous Electrical Stimulation on Swallowing in Patients With Oropharyngeal Dysphagia After Stroke

Resource links provided by NLM:


Further study details as provided by Hospital de Mataró:

Study Start Date: January 2012
Arms Assigned Interventions
Experimental: Sensory stimulation Device: VITALSTIM transcutaneous electrical stimulation
Experimental: Motor stimulation Device: VITALSTIM transcutaneous electrical stimulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Background of swallowing difficulties associated with stroke, more than 3 months of evolution
  • Study explained and signed informed consent

Exclusion Criteria:

  • Patients who are suspected or can not meet the protocol. patients who are participating or have participated in a trial last 4 weeks. Patients with active cancer Patients with active infectious process. patients with severe dementia or inability to communicate. patients with neurodegenerative diseases. patients with pacemakers. patients with implanted electrodes. patients with epilepsy or seizure disorders. patients with gastroesophageal reflux.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01363973

Locations
Spain
Hospital de Mataró
Mataró, Barcelona, Spain, 08304
Sponsors and Collaborators
Hospital de Mataró
Centro de Investigación Biomédica en Red
  More Information

No publications provided

Responsible Party: Pere Clave, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT01363973     History of Changes
Other Study ID Numbers: EETI-01
Study First Received: May 27, 2011
Last Updated: January 15, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital de Mataró:
oropharyngeal dysphagia
post-stroke

Additional relevant MeSH terms:
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on October 22, 2014