Trial record 13 of 221 for:    Open Studies | "Deglutition Disorders"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hospital de Mataró
Sponsor:
Collaborator:
Agrupació Mutua
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró
ClinicalTrials.gov Identifier:
NCT01762228
First received: October 10, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention
Dysphagia
Device: Transcutaneous electrical stimulation
Dietary Supplement: TRPV1 agonist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital de Mataró:

Primary Outcome Measures:
  • Oropharyngeal motor response measured by Videofluoroscopy. [ Time Frame: Week 1 and 5. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762228

Contacts
Contact: Omar Ortega Fernández, Biology +34 937417700 ext 2746 oortega@csdm.cat

Locations
Spain
Hospital de Mataró. Consorci Sanitari del Mareme. Recruiting
Mataró, Barcelona, Spain, 08304
Contact: Omar Ortega Fernández, MSc    +34 93 7417700 ext 2746    oortega@csdm.cat   
Contact: Pere Clavé, MD, PhD    +34 93 7417700 ext 2745    pclave@csdm.cat   
Sub-Investigator: Omar Ortega Fernández, MSc         
Principal Investigator: Pere Clavé, MD, PhD         
Sub-Investigator: Laia Rofes, MSc         
Sponsors and Collaborators
Hospital de Mataró
Agrupació Mutua
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
  More Information

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
Study First Received: October 10, 2012
Last Updated: January 7, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 26, 2014