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

NCT ID: NCT01777672

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31

Brief Summary

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.

Conditions

Dysphagia; Aspiration; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dietary and oral hygiene recommendations

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Dietary and oral hygiene recommendations

Intervention Type: BEHAVIORAL

oral TRPV1 agonist

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Dietary and oral hygiene recommendations

Intervention Type: BEHAVIORAL

pharyngeal electrical stimulation

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Dietary and oral hygiene recommendations

Intervention Type: BEHAVIORAL

transcutaneous electrical stimulation

Intervention Type: DEVICE

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

Dietary and oral hygiene recommendations

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Electrodes (Gaeltec, Ltd, Dunvegan, Isle of Skye, UK.; Electrical stimulator (Grass Instruments Co, USA); Intelect VitalStim, Chattanooga, USA)

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Mataró

OTHER

Sponsor Role: lead

Responsible Party

Pere Clave

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pere Pere, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataró, Gastrointestinal Physiology Laboratory

Locations

Hospital de Mataró

Mataró, Barcelona, Spain

Countries

Spain

Other Identifiers

Marató-11

Identifier Type: -

Identifier Source: org_study_id