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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Dysphagia

Intervention / Treatment
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* Device: Transcutaneous electrical stimulation
* Dietary Supplement: TRPV1 agonist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcutaneus electrical stimulation<br>Sensorial transcutaneous electrical stimulation to the pharynx and larynx will be used 1 hour/day during 5 days/week for 2 weeks. | Device: Transcutaneous electrical stimulation<br>* 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.<br>|
| Active Comparator: TRPV1 agonist<br>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. | Dietary Supplement: TRPV1 agonist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal motor response measured by Videofluoroscopy. |  | Week 1 and 5. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical activation measured by electroencephalography. |  | It will be assessed at the beginning and at the end of the study (first and fifth week). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oropharyngeal dysphagia, Elderly, Transcutaneous electrical stimulation, TRPV1 agonist