Oropharyngeal Dysphagia, Stroke, Stroke, Acute, Swallowing Disorder
Conditions
Keywords
TRPV1 agonists, TRPV1/A1 agonists, Transcranial Direct Current Stimulation, Non-invasive Brain Stimulation, Sensory Stimulation, Capsaicin
Brief 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.
Detailed description
* Main hypothesis: Paired neurorehabilitation treatment targeting both pharyngeal sensory and motor components simultaneously through a peripheral pharmacological stimulant (transient receptor potential cation channel \[TRPV1\] agonist, capsaicin) and central stimulation (NIBS) (tDCS) can improve swallowing function in acute PS-OD patients by promoting cortical plasticity, their QoL and reduce OD associated complications. * Main objectives: 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. * Secondary aims: to assess 1) safety and adverse events; 2) the effects on safety of swallow with a standardized protocol of swallowing evaluation; 3) clinical outcomes at 3 months follow up; 4) the effect of the treatments on spontaneous swallowing frequency and responsiveness to treatment according to stroke characteristics; 5) the effect in the acute phase on functional severity of OD and specific clinical outcomes. * Design: 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. * Study population: 60 Acute PS-OD hospitalized patients. * Inclusion criteria: Adult patients consecutively admitted with recent (\<1month) unilateral hemispheric stroke; impaired safety of swallow (ISS) (V-VST); conscious (NIHSS quest. 1a=0); able to follow the protocol and to give written informed consent (WIC). * Exclusion criteria: Pregnancy; life expectancy \<3m or palliative care; neurodegenerative disorder or previous OD; implanted electronic device; epilepsy; metal in the head; participation in another clinical trial in the previous month.
Interventions
COMBINATION_PRODUCTPiperine 150μM + tDCS 2mA
2 days treatment with either sham + placebo or piperine 150μM + tDCS 2mA (cross-over randomized study).
COMBINATION_PRODUCTPiperine 1mM + tDCS 2mA
2 days treatment with either sham + placebo or piperine 1mM + tDCS 2mA (cross-over randomized study).
COMBINATION_PRODUCTCapsaicin 10μM + tDCS 2mA
2 days treatment with either sham + placebo or capsaicin 10μM + tDCS 2mA (cross-over randomized study).
Sponsors
Consorci Sanitari del Maresme
Instituto de Salud Carlos III
Hospital de Mataró
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Blinding will be applicable for clinical and instrumental assessments for investigators, and for intervention condition for patients.
Intervention model description
2 days randomized crossover study with 60 patients in 3 treatment groups: * Piperine 150μM + tDCS 2mA 20' * Piperine 1mM+ tDCS 2mA 20' * Capsaicin 10μM + tDCS 2mA 20
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 infection * Participation in another clinical trial in the previous month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in swallowing function | Day 1, +24 hours, and at 3 months follow-up. | Changes in the volume-viscosity swallowing test to assess prevalence of signs of impaired efficacy and safety of swallow. Evaluated at visit baseline, post-treatment and at 3 months follow-up). |
| Changes in spontaneous swallowing frequency | Day 1, +24 hours, and at 3 months follow-up. | Changes in the electromyographical evaluation of spontaneous swallowing frequency obtaining the number of swallows/min, the amplitude and the latency of swallows. 5 times pre-post treatment visits 1 and pre-post treatment visit 2 and 1 time at 3 months follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioimpedance | Day 1, +24 hours, and at 3 months follow-up. | Bioimpedance parameters (total body water, extracellular water, intracellular water, phase angle, muscle mass and cell mass) |
| Blood analysis | Baseline and 3 months follow-up visits. | Analytical parameters (albumin, pre-albumin, total protein, total lymphocytes and total cholesterol). |
| Neuropeptides in saliva determination | Day 1, +24 hours, and at 3 months follow-up. | Determination by ELISA of concentration of the neuropeptides substance P and CGRP (Calcitonin gene-related peptide) in saliva sample. |
| Length of hospital stay | From baseline to the end of the study (3-months follow-up visit). | length of stay during the study. |
| Nutritional status (MNA-sf) | Baseline and 3 months follow-up visits. | Mini nutritional assessment short form score (nutritional status questionnaire). |
| General hospital readmissions | From baseline to the end of the study (3-months follow-up visit). | General hospital readmissions by any cause during the study period. |
| Mortality over the study period | From baseline to the end of the study (3-months follow-up visit). | Mortality over the study period. |
| Safety of the treatment | From baseline to the end of the study (3-months follow-up visit). | Safety of the treatment applied (adverse events rate) during all the study period. |
| Aspiration pneumonia admissions | From baseline to the end of the study (3-months follow-up visit). | Aspiration pneumonia admissions during the study period. |
| Anthropometrics | Baseline and 3 months follow-up visits. | Weight, height and body mass index. |
Countries
Spain
Contacts
Primary ContactPere Clavé, MD, PhD
Backup ContactOmar Ortega, PhD
Outcome results
None listed