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Recruiting
NCT05720871
Treatment of Chronic Post-stroke Oropharyngeal Dysphagia With Paired Stimulation
Conditions: Oropharyngeal Dysphagia, Stroke, Stroke, Complication, Swallowing Disorder
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
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 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.
Eligibility Criteria
Inclusion Criteria:Chronic (>3 and <24 months) unilateral hemispheric stroke adult patients.Patients with impaired safety of swallow with a penetration-aspiration score (PAS) ≥ 2 with videofluoroscopy (VFS).Patient able to follow the study protocol and give the written informed consent.Exclusion Criteria:Pregnancy.Life expectancy less than 3m or palliative care.Neurodegenerative disorder.Previously diagnosed oropharyngeal dysphagia (dysphagia not related to stroke).Implanted electronic device.Epilepsy.Metal in the head.Participation in another clinical trial in the previous month.
Source: ClinicalTrials.gov (NCT05720871). StuddyBuddy aggregates publicly available trial information.