Treatment of Chronic 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 and of central motor noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) will be studied. Pairing pharmacological peripheral and central stimulation may produce greater benefits. The main aim of the project is to study the efficacy of two novel protocols of paired stimulation on PS-OD patients. The investigators will assess whether 5-day application of tDCS/capsaicin or rTMS/capsaicin in the chronic phase of stroke, will improve PS-OD. One RCT (200 patients in the chronic stroke phase divided in 4 study arms) will assess changes in swallow safety, biomechanics and neurophysiology of the swallow response, hospital stay, respiratory and nutritional complications, mortality and QoL.

Conditions

• Oropharyngeal Dysphagia
• Stroke
• Stroke, Complication
• Swallowing Disorder

Interventions

DEVICE

rTMS + capsaicin 150μM (natural TRPV1 agonist)

Repetitive transcranial magnetic stimulation (non-invasive brain stimulation) + Capsaicin. 5 consecutive days of active treatment consists of swallowing 10mL capsaicin (150μM) and, just after, of applying focal (alpha D70 coil) rTMS (Magstim Rapid2, UK) over the pharyngeal M1 hotspot of the unaffected hemisphere. A total of 500 pulses/session are delivered consisting of 10 5Hz-trains of 10s of 50 pulses each (total 2500 pulses), with a 1min interval between trains at an intensity of 90% of the resting motor threshold (RMT). The intervention has its respective sham rTMS+placebo group that is also applied over 5 consecutive days.

DEVICE

tDCS + capsaicin 150μM (natural TRPV1 agonist)

Transcranial direct current stimulation (non-invasive brain stimulation) + Capsaicin. Treatment consists of swallowing 10mL capsaicin (150μM) and, just after, of applying 30min of 2.0mA tDCS (DC-Stimulator Plus, NeuroConn, Germany) with the anode placed over the pharyngeal primary motor cortex (M1) of the unaffected hemisphere (3.5cm lateral / 1cm anterior to the vertex) and the cathode over the opposite supraorbital region. The intervention has its respective sham tDCS+placebo group that is also applied over 5 consecutive days.

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

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-28

Primary Completion

2024-12-31

Completion

2025-09-30

Countries

• Spain

Study Locations