Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia

February 7, 2017 updated by: Pere Clave, Hospital de Mataró

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Person with persistent clinical signs or symptoms of OD according to V-VST and confirmed with VFS (PA scale level 3 or more) secondary to a stroke episode in the last 3 months.

Exclusion Criteria:

  • Patient unconscious or in a coma
  • Patients diagnosed with transitory ischemic accident
  • life expectancy less than 3 months
  • neurodegenerative disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dietary and oral hygiene recommendations
Patients in this group will receive recommendations from their healthcare providers about bolus volume and viscosity adaptation for fluids, dietary and nutritional adjustments (liquids and solids) of bolus volume and viscosity/texture. Before leaving each hospital they will also learn basic rehabilitation strategies for OD including swallow postures, compensatory manoeuvres and oropharyngeal rehabilitation exercises and oral hygiene to follow at home.
Behavioral: Dietary and oral hygiene recommendations
Experimental: oral TRPV1 agonist
Patients will receive the same recommendations as the control group and also recommendation for the administration of a TRPV1 agonist (natural capsaicin) supplement (5 mL bolus before each meal), 3 meals/day, 5 days/week for 2 consecutive weeks.
Behavioral: Dietary and oral hygiene recommendations
Dietary supplement: oral TRPV1 agonist
Patients will receive the administration of a TRPV1 agonist (natural capsaicin) supplement before each meal, 3 meals/day, 5 days/week for 2 consecutive weeks. The TRPV1 agonist will be provided by the pharmacy of the center.
Experimental: pharyngeal electrical stimulation
Treatment in this group will also include the same measures as in the control group, plus neuron stimulation treatment of 1 session / day of pharyngeal electrical stimulation of 10 min duration, 3 days/week during one week, done at the same center.
Behavioral: Dietary and oral hygiene recommendations
Device: pharyngeal electrical stimulation
Includes neuron stimulation treatment of 1 session / day of pharyngeal electrical stimulation of 10 min duration, 3 days/week during 1 week, done at the same center.
Other Names:
  • Electrodes (Gaeltec, Ltd, Dunvegan, Isle of Skye, UK.
  • Electrical stimulator (Grass Instruments Co, USA)
Experimental: transcutaneous electrical stimulation
Treatment in this group will be the same as the control group plus trans-cutaneous electrical stimuli will be applied 5 seconds every minute during 1 hour daily session, 5 days/week during 2 consecutive weeks at the same centre.
Behavioral: Dietary and oral hygiene recommendations
Device: transcutaneous electrical stimulation
Trans-cutaneous electrical stimuli will be applied 5 seconds every minute during 1 hour daily session, 5 days/week during 2 consecutive weeks at the same centre.
Other Names:
  • Intelect VitalStim, Chattanooga, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 respiratory tract infections, nutritional status, complications and clinical symptoms experimented during one year of follow-up and mortality rates and cause of death.

Participating clinicians will be instructed to register and describe all serious adverse events (SAE) occurred during the study and report them on a specific form within 24 hours. The guidelines for SAE reporting to the Ethical Committee and competent authorities will be followed.
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the prevalence of OD and its complications in stroke patients over one year.
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
To assess and compare one year health resource consumption between all study treatment groups.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Mataró

Investigators

  • Principal Investigator: Pere Pere, Doctor, Hospital de Mataró, Gastrointestinal Physiology Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Marató-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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