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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 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 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.

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.


Sponsor: Hospital de Mataró

Current Primary Outcome: Oropharyngeal motor response measured by Videofluoroscopy. [ Time Frame: Week 1 and 5. ]

Original Primary Outcome: Oropharyngeal motor response measured by Videofluoroscopy [ Time Frame: It will be assesed at the beggining and at the end of the study (first and fifth week). ]

Current Secondary Outcome: Cortical activation measured by electroencephalography. [ Time Frame: It will be assessed at the beginning and at the end of the study (first and fifth week). ]

Original Secondary Outcome: Cortical neuroplasticity measured by Electroencephalography. [ Time Frame: It will be assesed at the beggining and at the end of the study (first and fifth week). ]

Information By: Hospital de Mataró

Dates:
Date Received: October 10, 2012
Date Started: November 2012
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015