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

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ClinicalTrials.gov Identifier: NCT01762228
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pere Clave, 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.


Condition or disease Intervention/treatment Phase
Dysphagia Device: Transcutaneous electrical stimulation Dietary Supplement: TRPV1 agonist Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Dysphagia.
Study Start Date : November 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Transcutaneus electrical stimulation
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
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.
Active Comparator: 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.
Dietary Supplement: TRPV1 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.



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

Secondary Outcome Measures :
  1. 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). ]


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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762228


Locations
Spain
Hospital de Mataró. Consorci Sanitari del Mareme.
Mataró, Barcelona, Spain, 08304
Sponsors and Collaborators
Hospital de Mataró
Investigators
Principal Investigator: Omar Ortega Fernández, MSc Hospital de Mataró
Study Director: Pere Clavé, MD, PhD Hospital de Mataró
Principal Investigator: Laia Rofes, MSc Hospital de Mataró

Additional Information:
Publications:

Responsible Party: Pere Clave, Pere Clavé, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT01762228     History of Changes
Other Study ID Numbers: MUTUA-12
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Pere Clave, Hospital de Mataró:
Oropharyngeal dysphagia
Elderly
Transcutaneous electrical stimulation
TRPV1 agonist

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases