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

Dysphagia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762228
• Other study ID #: MUTUA-12
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: March 17, 2015
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Hospital de Mataró
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de Mataró. Consorci Sanitari del Mareme.	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Hamamoto T, Takumida M, Hirakawa K, Tatsukawa T, Ishibashi T. Localization of transient receptor potential vanilloid (TRPV) in the human larynx. Acta Otolaryngol. 2009 May;129(5):560-8. doi: 10.1080/00016480802273108. — View Citation

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

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

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal motor response measured by Videofluoroscopy.		Week 1 and 5.	Yes
Secondary	Cortical activation measured by electroencephalography.		It will be assessed at the beginning and at the end of the study (first and fifth week).	No

External Links

•   European Society for Swallowing Disorders