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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

October 10, 2012
January 7, 2013
March 19, 2015
November 2012
December 2014   (Final data collection date for primary outcome measure)
Oropharyngeal motor response measured by Videofluoroscopy. [ Time Frame: Week 1 and 5. ]
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). ]
Complete list of historical versions of study NCT01762228 on ClinicalTrials.gov Archive Site
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). ]
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). ]
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Dysphagia
  • 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.
  • 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.
  • 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.
    Intervention: Device: Transcutaneous electrical stimulation
  • 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.
    Intervention: Dietary Supplement: TRPV1 agonist

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
40
March 2015
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
70 Years and older   (Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01762228
MUTUA-12
Yes
Not Provided
Not Provided
Pere Clave, Hospital de Mataró
Hospital de Mataró
Not Provided
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
Hospital de Mataró
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP