NCT01777672

Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia (OD). A Randomized Controlled Trial.

Completed Phase 2 Last updated 7 February 2017

What this trial tests

Phase 2 trial testing Dietary and oral hygiene recommendations in Dysphagia in 100 participants. Completed.

Timeline

1 October 2012

Primary endpoint
1 June 2016

Quick facts

Lead sponsor	Hospital de Mataró
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 October 2012
Primary completion	1 June 2016
Sites	1 location across Spain

Drugs / interventions tested

• Dietary and oral hygiene recommendations
• oral TRPV1 agonist
• pharyngeal electrical stimulation
• transcutaneous electrical stimulation

Conditions studied

• Dysphagia — all drugs for Dysphagia →
• Aspiration — all drugs for Aspiration →
• Stroke — all drugs for Stroke →

Sponsor

Hospital de Mataró

Who can join

Eligibility, any sex, with Dysphagia or Aspiration. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To assess the efficacy and safety of new neuron-stimulation treatments for OD in patients with stroke and to explore their mechanism of action.
  Time frame: 12 months
  The efficacy of each treatment will be assessed by VFS in each patient after the treatment and at the end of the follow-up period, considering Rosenbek scale and measures of oropharyngeal swallow response including oropharyngeal reconfiguration, timing and extent of hyoid motion and bolus propulsion force of the tongue. Clinical outcome also evaluated are episodes of aspiration pneumonia and low r

Sponsor's own description

Oropharyngeal dysphagia (OD) is a major complaint among many patients with stroke and causes severe complications. There is no specific treatment for these patients. Impaired swallow response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed airway protection. Swallow response is initiated by sensory afferent fibers in the oropharynx and cerebral cortex reaching the central swallowing pattern generator (CPG) in the medulla oblongata and brainstem motor nuclei. Hypothesis: Stimulation of pharyngeal sensory afferent fibers through TRPV1 receptors and electrical stimuli might enhance the stimulation of the CPG and speed the swallow response. Long-term treatment of OD will improve clinical outcome of stroke patients. Aim: To assess the effect of TRPV1 agonists (capsaicin) and that of sensorial pharyngeal electrical stimulation (intrapharyngeal and transcutaneous) on VFS signs and swallow response at 3, 6 and 12 months after treatment in stroke patients with established OD. To compare the clinical effect of classical rehabilitation strategies with that of these new afferent sensorial neurostimulation strategies in terms of nutritional status parameters, incidence of aspiration pneumonia and/or low respiratory tract infection, quality of life, and mortality. Methods: Clinical screening of OD with the volume-viscosity swallow test and assessment by VFS and quantitative measurements of swallow response. Randomized controlled trial assessing the effect of standard rehabilitation with that of afferent sensorial neurostimulation strategies.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Swallowing therapy for dysphagia in acute and subacute stroke.
   Bath PM, Lee HS, Everton LF. · · 2018 · cited 160× · PMID 30376602 · DOI 10.1002/14651858.cd000323.pub3
2. Interventions for improving oral health in people after stroke.
   Campbell P, Bain B, Furlanetto DL, Brady MC. · · 2020 · cited 20× · PMID 33314046 · DOI 10.1002/14651858.cd003864.pub3