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Recruiting NCT05735626

Treatment of Acute Post-stroke Oropharyngeal Dysphagia With Paired Stimulation

Conditions: Stroke, Stroke, Acute, Oropharyngeal Dysphagia, Swallowing Disorder

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: Hospital de Mataró

Location: Spain

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.

Eligibility Criteria

Inclusion Criteria:Unilateral acute stroke (up to 15 days of evolution).Impaired safety or efficacy of swallow according the volume-viscosity swallowing test (V-VST).Conscious patient (NIHSS 1a = 0).Patient able to follow the protocol and give written informed consent or, failing that, by a family member or legal representative.Exclusion Criteria:Pregnancy.Life expectancy less than 3m or palliative care.Neurodegenerative disorder.Comprehension aphasia.Dementia (GDS 4 or higher).Previously diagnosed oropharyngeal dysphagia (dysphagia not related to stroke).Implanted electronic device.Epilepsy.Metal in the head.Patients with suspected or PCR-confirmed SARS-CoV-2 infectionParticipation in another clinical trial in the previous month.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05735626). StuddyBuddy aggregates publicly available trial information.