Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients

NCT ID: NCT01363973

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sensory stimulation

Transcutaneous electrical stimulation at 75% of motor threshold

Group Type: EXPERIMENTAL

VITALSTIM transcutaneous electrical stimulation

Intervention Type: DEVICE

Motor stimulation

Transcutaneous electrical stimulation at motor threshold

Group Type: EXPERIMENTAL

VITALSTIM transcutaneous electrical stimulation

Intervention Type: DEVICE

Interventions

VITALSTIM transcutaneous electrical stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role: collaborator

Hospital de Mataró

OTHER

Sponsor Role: lead

Responsible Party

Pere Clave

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Mataró

Mataró, Barcelona, Spain

Countries

Spain

Other Identifiers

EETI-01

Identifier Type: -

Identifier Source: org_study_id