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.
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

January 21, 2013
January 28, 2013
October 2012
December 2014   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01777672 on ClinicalTrials.gov Archive Site
To determine the prevalence of OD and its complications in stroke patients over one year. [ Time Frame: 12 months ]
Same as current
To assess and compare one year health resource consumption between all study treatment groups. [ Time Frame: 12 months ]
Same as current
 
Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Dysphagia,
  • Aspiration,
  • Swallow Response,
  • Videofluoroscopy,
  • Sensorial Neurostimulation.
  • 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.
  • 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)
  • 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)
  • 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.
    Intervention: 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.
    Interventions:
    • Behavioral: Dietary and oral hygiene recommendations
    • Dietary Supplement: oral TRPV1 agonist
  • 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.
    Interventions:
    • Behavioral: Dietary and oral hygiene recommendations
    • Device: pharyngeal electrical stimulation
  • 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.
    Interventions:
    • Behavioral: Dietary and oral hygiene recommendations
    • Device: transcutaneous electrical stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Pere Clavé, Doctor 937417700 ext 2746 pclave@csdm.cat
Spain
 
NCT01777672
Marató-11
Not Provided
Pere Clave, Hospital de Mataró
Hospital de Mataró
Not Provided
Not Provided
Hospital de Mataró
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP