Efficacy of Two Interventions Increasing Sensory Stimulus in Elderly Patients With Oropharyngeal Dysphagia - Full Text View

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:

Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
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:

MedlinePlus related topics: Swallowing Disorders

U.S. FDA Resources

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:

Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
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

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:

European Society for Swallowing Disorders This link exits the ClinicalTrials.gov site

Publications:

Rofes L, Arreola V, Romea M, Palomera E, Almirall J, Cabré M, Serra-Prat M, Clavé P. Pathophysiology of oropharyngeal dysphagia in the frail elderly. Neurogastroenterol Motil. 2010 Aug;22(8):851-8, e230. doi: 10.1111/j.1365-2982.2010.01521.x. Epub 2010 Jun 7.

Clavé P, Arreola V, Romea M, Medina L, Palomera E, Serra-Prat M. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr. 2008 Dec;27(6):806-15. doi: 10.1016/j.clnu.2008.06.011. Epub 2008 Sep 11.

Jean A. Brain stem control of swallowing: neuronal network and cellular mechanisms. Physiol Rev. 2001 Apr;81(2):929-69. Review.

Ebihara T, Sekizawa K, Nakazawa H, Sasaki H. Capsaicin and swallowing reflex. Lancet. 1993 Feb 13;341(8842):432.

Ebihara T, Takahashi H, Ebihara S, Okazaki T, Sasaki T, Watando A, Nemoto M, Sasaki H. Capsaicin troche for swallowing dysfunction in older people. J Am Geriatr Soc. 2005 May;53(5):824-8.

Caterina MJ, Schumacher MA, Tominaga M, Rosen TA, Levine JD, Julius D. The capsaicin receptor: a heat-activated ion channel in the pain pathway. Nature. 1997 Oct 23;389(6653):816-24.

Carnaby-Mann GD, Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg. 2007 Jun;133(6):564-71.

Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, Dowdy E. Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Ann Otol Rhinol Laryngol. 2007 Jan;116(1):36-44.

Gallas S, Marie JP, Leroi AM, Verin E. Sensory transcutaneous electrical stimulation improves post-stroke dysphagic patients. Dysphagia. 2010 Dec;25(4):291-7. doi: 10.1007/s00455-009-9259-3. Epub 2009 Oct 24.

Logemann JA. Dysphagia: evaluation and treatment. Folia Phoniatr Logop. 1995;47(3):140-64. Review.

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 May 23, 2013