Efficacy of Two Interventions Increasing Sensory Stimulus in Elderly Patients With Oropharyngeal Dysphagia
NCT ID: NCT01762228
Last Updated: 2015-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2012-11-30
2015-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients have to fill in and sign the written informed consent.
Exclusion Criteria
* 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.
70 Years
ALL
No
Sponsors
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Hospital de Mataró
OTHER
Responsible Party
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Pere Clave
Pere Clavé, MD, PhD
Principal Investigators
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Omar Ortega Fernández, MSc
Role: PRINCIPAL_INVESTIGATOR
Hospital de Mataró
Pere Clavé, MD, PhD
Role: STUDY_DIRECTOR
Hospital de Mataró
Laia Rofes, MSc
Role: PRINCIPAL_INVESTIGATOR
Hospital de Mataró
Locations
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Hospital de Mataró. Consorci Sanitari del Mareme.
Mataró, Barcelona, Spain
Countries
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References
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Rofes L, Arreola V, Romea M, Palomera E, Almirall J, Cabre M, Serra-Prat M, Clave 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.
Clave 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. doi: 10.1152/physrev.2001.81.2.929.
Ebihara T, Sekizawa K, Nakazawa H, Sasaki H. Capsaicin and swallowing reflex. Lancet. 1993 Feb 13;341(8842):432. doi: 10.1016/0140-6736(93)93023-t. No abstract available.
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. doi: 10.1111/j.1532-5415.2005.53261.x.
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. doi: 10.1038/39807.
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.
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. doi: 10.1001/archotol.133.6.564.
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. doi: 10.1177/000348940711600107.
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. doi: 10.1159/000266348.
Related Links
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European Society for Swallowing Disorders
Other Identifiers
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MUTUA-12
Identifier Type: -
Identifier Source: org_study_id
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