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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01363973
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Dysphagia Device: VITALSTIM transcutaneous electrical stimulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Study Start Date : January 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sensory stimulation
Transcutaneous electrical stimulation at 75% of motor threshold
Device: VITALSTIM transcutaneous electrical stimulation
Experimental: Motor stimulation
Transcutaneous electrical stimulation at motor threshold
Device: VITALSTIM transcutaneous electrical stimulation

Outcome Measures

Primary Outcome Measures :
  1. Safety of swallow [ Time Frame: 5 days ]
    Prevalence of penetrations or aspirations after the treatment

Secondary Outcome Measures :
  1. Efficacy of swallow [ Time Frame: 5 days ]
    Prevalence of residue after the treatment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363973

Hospital de Mataró
Mataró, Barcelona, Spain, 08304
Sponsors and Collaborators
Hospital de Mataró
Consorcio Centro de Investigación Biomédica en Red, M.P.
More Information

Responsible Party: Pere Clave, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT01363973     History of Changes
Other Study ID Numbers: EETI-01
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015

Keywords provided by Pere Clave, Hospital de Mataró:
oropharyngeal dysphagia

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