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.
Verified date | March 2015 |
Source | Hospital de Mataró |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Mataró. Consorci Sanitari del Mareme. | Mataró | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital de Mataró |
Spain,
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
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 |
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