Treatment of Acute Post-stroke Oropharyngeal Dysphagia With Paired Stimulation

Summary

According WHO, oropharyngeal dysphagia (OD) is a prevalent post-stroke (PS) condition involving the digestive system (ICD-10: I69.391) and an independent risk factor for malnutrition and pulmonary infection; and leads to greater morbimortality and healthcare costs and poorer quality of life (QoL). Currently, OD therapy is mainly compensatory, with low rates of compliance and small benefit, and there is no pharmacological treatment, so new treatments that improve patients' condition are crucial. PS-OD patients present both oropharyngeal sensory and motor deficits, so neurorehabilitation treatments which target both could be optimum. Benefits of paired peripheral sensory stimulation with oral capsaicin or piperine and of central motor noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) will be studied. Pairing sensory peripheral and central stimulation may produce greater benefits. The main aim of the project is to study the efficacy of a novel protocol of paired stimulation on acute PS-OD patients. The investigators will assess the acute application of tDCS/piperine or tDCS/capsaicin in the acute phase of stroke, will improve PS-OD. 2 days randomized crossover study with 60 patients in 3 treatment groups (60 patients in the acute stroke phase divided in 3 study arms). We will assess changes in swallow safety, and neurophysiology of the swallow, hospital stay, respiratory and nutritional complications, mortality and QoL.

Conditions

• Stroke
• Stroke, Acute
• Oropharyngeal Dysphagia
• Swallowing Disorder

Interventions

COMBINATION_PRODUCT

Piperine 150μM + tDCS 2mA

2 days treatment with either sham + placebo or piperine 150μM + tDCS 2mA (cross-over randomized study).

COMBINATION_PRODUCT

Piperine 1mM + tDCS 2mA

2 days treatment with either sham + placebo or piperine 1mM + tDCS 2mA (cross-over randomized study).

COMBINATION_PRODUCT

Capsaicin 10μM + tDCS 2mA

2 days treatment with either sham + placebo or capsaicin 10μM + tDCS 2mA (cross-over randomized study).

Sponsors & Collaborators

• Consorci Sanitari del Maresme

  collaborator OTHER

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Hospital de Mataró

  lead OTHER

Principal Investigators

• Pere Clavé, MD, PhD · Consorci Sanitari del Maresme

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2023-12-31

Completion

2024-04-30

Countries

• Spain

Study Locations