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

Randomized Controled Clinical Study to Evaluate the Efficacy of the Increase of the Sensorial Stimuli as a Therapeutic Strategy for the Treatment of Elderly Patients With Oropharyngeal Dysphagia.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01762228
Enrollment
28
Registered
2013-01-07
Start date
2012-11-30
Completion date
2015-03-31
Last updated
2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Oropharyngeal dysphagia, Elderly, Transcutaneous electrical stimulation, TRPV1 agonist

Brief summary

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.

Detailed 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: 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. 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.

Interventions

DEVICETranscutaneous electrical stimulation

Using a device which gives electrical stimulation, electrodes will be placed transcutaneously in oropharyngeal muscles of patients giving a sensorial stimuli during one hour for 5 days/week during 2 weeks of treatment.

DIETARY_SUPPLEMENTTRPV1 agonist

Patient will be given a TRPV1 agonist natural product (which contains capsaicin) before every meal, during one hour for 5 days/week during 2 weeks of treatment.

Sponsors

Hospital de Mataró
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

.

Design outcomes

Primary

MeasureTime frame
Oropharyngeal motor response measured by Videofluoroscopy.Week 1 and 5.

Secondary

MeasureTime frame
Cortical activation measured by electroencephalography.It will be assessed at the beginning and at the end of the study (first and fifth week).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026