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

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
VITALSTIM transcutaneous electrical stimulation
Sponsored by
Hospital de Mataró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring oropharyngeal dysphagia, post-stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Mataró

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sensory stimulation

Motor stimulation

Arm Description

Transcutaneous electrical stimulation at 75% of motor threshold

Transcutaneous electrical stimulation at motor threshold

Outcomes

Primary Outcome Measures

Safety of swallow
Prevalence of penetrations or aspirations after the treatment

Secondary Outcome Measures

Efficacy of swallow
Prevalence of residue after the treatment

Full Information

First Posted
May 27, 2011
Last Updated
February 27, 2015
Sponsor
Hospital de Mataró
Collaborators
Consorcio Centro de Investigación Biomédica en Red (CIBER)
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1. Study Identification

Unique Protocol Identification Number
NCT01363973
Brief Title
Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients
Acronym
EETI-01
Official Title
Pilot Study to Evaluate the Efficacy and Safety of Transcutaneous Electrical Stimulation on Swallowing in Patients With Oropharyngeal Dysphagia After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró
Collaborators
Consorcio Centro de Investigación Biomédica en Red (CIBER)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
oropharyngeal dysphagia, post-stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensory stimulation
Arm Type
Experimental
Arm Description
Transcutaneous electrical stimulation at 75% of motor threshold
Arm Title
Motor stimulation
Arm Type
Experimental
Arm Description
Transcutaneous electrical stimulation at motor threshold
Intervention Type
Device
Intervention Name(s)
VITALSTIM transcutaneous electrical stimulation
Primary Outcome Measure Information:
Title
Safety of swallow
Description
Prevalence of penetrations or aspirations after the treatment
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Efficacy of swallow
Description
Prevalence of residue after the treatment
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

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Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients

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