Efficacy of Two Interventions Increasing Sensory Stimulus in Elderly Patients With Oropharyngeal Dysphagia

Hospital de Mataró

Status: Completed

Conditions: Dysphagia

Treatments: Device: Transcutaneous electrical stimulation; Dietary Supplement: TRPV1 agonist

Study type: Interventional

Funder types: Other

Identifiers

NCT01762228

MUTUA-12

Details and patient eligibility

About

This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:

1. Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
2. Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.

Moreover, with an electroencephalographic study we will assess the effect of both treatments in the cortical neuroplasticity.

Full description

This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:

Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus. Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.

The study will last 5 weeks per patient. At the beginning of the study, patients will receive a videofluoroscopic evaluation and an electroencephalography (evoked potentials) to asses dysphagia and cortical activity of deglutition. After that the first day of the third week they will begin the treatment (group a or b) during 2 weeks. Finally in the fifth week an evaluation of dysphagia will be performed the same way as in week 1 to asses the effects of the treatments.

Enrollment: 28 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elderly patients (≥70 years) with oropharyngeal dysphagia (OD)
• Patients have to fill in and sign the written informed consent.
• Patients without any of the exclusion criteria.

Exclusion criteria

• Patients not able to comply with the protocol.
• Patients currently participating or having participated in another clinical trial in the last 4 weeks.
• Patients with active neoplasia.
• Patients with an active infectious process.
• Patients with severe dementia or inability to communicate.
• Patients with pacemakers.
• Patients with implanted electrodes.
• Patients with epilepsy or convulsive disorders.
• Patients with gastroesophageal reflux disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Transcutaneus electrical stimulation

Active Comparator group

Description:

Sensorial transcutaneous electrical stimulation to the pharynx and larynx will be used 1 hour/day during 5 days/week for 2 weeks.

Treatment:

Device: Transcutaneous electrical stimulation

TRPV1 agonist

Active Comparator group

Description:

Sensorial stimulation of TRPV1 receptors into the oropharynx of patients will be used 3 times/day (before meals) during 5 days/week for 2 weeks.

Treatment:

Dietary Supplement: TRPV1 agonist