NCT01363973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

May 27, 2011

Last Update Submit

February 27, 2015

Conditions

Dysphagia

Keywords

oropharyngeal dysphagiapost-stroke

Outcome Measures

Primary Outcomes (1)

  • Safety of swallow

    Prevalence of penetrations or aspirations after the treatment

    5 days

Secondary Outcomes (1)

  • Efficacy of swallow

    5 days

Study Arms (2)

Sensory stimulation

EXPERIMENTAL

Transcutaneous electrical stimulation at 75% of motor threshold

Device: VITALSTIM transcutaneous electrical stimulation

Motor stimulation

EXPERIMENTAL

Transcutaneous electrical stimulation at motor threshold

Device: VITALSTIM transcutaneous electrical stimulation

Interventions

VITALSTIM transcutaneous electrical stimulationDEVICE
Motor stimulationSensory stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 2, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 3, 2015

Record last verified: 2015-02

Locations

ES(1)