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

Not Applicable

Completed

• Conditions: Dysphagia
• Interventions: Dietary Supplement: TRPV1 agonist; Device: Transcutaneous electrical stimulation

• Registration Number: NCT01762228
• Lead Sponsor: Hospital de Mataró

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.

Study Timeline

• Study First Submitted: 2012-10-10
• Study Start: 2012-11
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Primary Completion: 2014-12
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRPV1 agonist	TRPV1 agonist	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.
Transcutaneus electrical stimulation	Transcutaneous electrical stimulation	Sensorial transcutaneous electrical stimulation to the pharynx and larynx will be used 1 hour/day during 5 days/week for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Oropharyngeal motor response measured by Videofluoroscopy.	Week 1 and 5.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Mataró. Consorci Sanitari del Mareme.; 🇪🇸 Mataró, Barcelona, Spain