Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Device: VITALSTIM transcutaneous electrical stimulation

• Registration Number: NCT01363973
• Lead Sponsor: Hospital de Mataró

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Study Start: 2012-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-27
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sensory stimulation	VITALSTIM transcutaneous electrical stimulation	Transcutaneous electrical stimulation at 75% of motor threshold
Motor stimulation	VITALSTIM transcutaneous electrical stimulation	Transcutaneous electrical stimulation at motor threshold

Primary Outcome Measures

Name	Time	Method
Safety of swallow	5 days	Prevalence of penetrations or aspirations after the treatment

Secondary Outcome Measures

Name	Time	Method
Efficacy of swallow	5 days	Prevalence of residue after the treatment

Trial Locations

Locations (1)

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain