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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hospital de Mataró
Sponsor:
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró
ClinicalTrials.gov Identifier:
NCT01777672
First received: January 21, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Dysphagia,
Aspiration,
Swallow Response,
Videofluoroscopy,
Sensorial Neurostimulation.
Behavioral: Dietary and oral hygiene recommendations
Dietary Supplement: oral TRPV1 agonist
Device: pharyngeal electrical stimulation
Device: transcutaneous electrical stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hospital de Mataró:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • To determine the prevalence of OD and its complications in stroke patients over one year. [ Time Frame: 12 months ]

Other Outcome Measures:
  • To assess and compare one year health resource consumption between all study treatment groups. [ Time Frame: 12 months ]

Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Intelect VitalStim, Chattanooga, USA)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777672

Contacts
Contact: Pere Clavé, Doctor 937417700 ext 2746 pclave@csdm.cat

Locations
Spain
Hospital de Mataró Recruiting
Mataró, Barcelon, Spain, 08304
Contact: Pere Clavé, MD, PhD    937417700 ext 2745    pclave@csdm.cat   
Sub-Investigator: Natàlia Vilardell, MSc         
Sponsors and Collaborators
Hospital de Mataró
  More Information

No publications provided

Responsible Party: Pere Clave, MD, PhD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT01777672     History of Changes
Other Study ID Numbers: Marató-11
Study First Received: January 21, 2013
Last Updated: January 28, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014