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

H

Hospital de Mataró

Status

Completed

Conditions

Dysphagia

Treatments

Device: Transcutaneous electrical stimulation
Dietary Supplement: TRPV1 agonist

Study type

Interventional

Funder types

Other

Identifiers

NCT01762228
MUTUA-12

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Transcutaneus electrical stimulation
Active Comparator group
Description:
Sensorial transcutaneous electrical stimulation to the pharynx and larynx will be used 1 hour/day during 5 days/week for 2 weeks.
Treatment:
Device: Transcutaneous electrical stimulation
TRPV1 agonist
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: TRPV1 agonist

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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