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| Name | Class |
|---|---|
| Consorci Sanitari del Maresme | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piperine 150μM + tDCS 2mA | Experimental | tDCS will be applied for 20 minutes at 2.0 mA (NeuroConn, Germany) with the anode electrode positioned over the pharyngeal primary motor cortex (M1) of the unaffected hemisphere (3.5 cm lateral / 1 cm anterior to the vertex) and the cathode over the opposite supraorbital region. During central stimulation, 5 ml of piperine (150μM) will be administered orally every 5 min. After each administration, the patient will be asked to perform dry swallows every minute. In order to avoid alterations in the safety and efficacy of swallowing during the procedure, the bolus will be rheologically adapted according to the patient's requirements. Crossover study, each arm includes a placebo + sham stimulation in one of the two days of treatment. Patients will initiate either placebo + sham stimulation or piperine + tDCS randomly in the first or second day depending on the randomization. |
|
| Piperine 1mM+ tDCS 2mA | Experimental | tDCS will be applied for 20 minutes at 2.0 mA with the anode electrode positioned over the pharyngeal primary motor cortex (M1) of the unaffected hemisphere (3.5 cm lateral / 1 cm anterior to the vertex) and the cathode over the opposite supraorbital region. During central stimulation, 5 ml of piperine (1 mM) will be administered orally every 5 min. After each administration, the patient will be asked to perform dry swallows every minute. In order to avoid alterations in the safety and efficacy of swallowing during the procedure, the bolus will be rheologically adapted according to the patient's requirements. Crossover study, each arm includes a placebo + sham stimulation in one of the two days of treatment. Patients will initiate either placebo + sham stimulation or piperine + tDCS randomly in the first or second day depending on the randomization. |
|
| Capsaicin 10μM + tDCS 2mA | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperine 150μM + tDCS 2mA | Combination Product | 2 days treatment with either sham + placebo or piperine 150μM + tDCS 2mA (cross-over randomized study). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in swallowing function | 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). | Day 1, +24 hours, and at 3 months follow-up. |
| Changes in spontaneous swallowing frequency | 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. | Day 1, +24 hours, and at 3 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status (MNA-sf) | Mini nutritional assessment short form score (nutritional status questionnaire). | Baseline and 3 months follow-up visits. |
| Anthropometrics | Weight, height and body mass index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pere Clavé, MD, PhD | Contact | +34937417700 | 1046 | pclave@csdm.cat |
| Omar Ortega, PhD | Contact | +34937417700 | 2284 | oortega@csdm.cat |
| Name | Affiliation | Role |
|---|---|---|
| Pere Clavé, MD, PhD | Consorci Sanitari del Maresme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataró. Consorci Sanitari del Mareme. | Recruiting | Mataró | Barcelona | 08304 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9291902 | Result | Hamdy S, Aziz Q, Rothwell JC, Crone R, Hughes D, Tallis RC, Thompson DG. Explaining oropharyngeal dysphagia after unilateral hemispheric stroke. Lancet. 1997 Sep 6;350(9079):686-92. doi: 10.1016/S0140-6736(97)02068-0. | |
| 27398981 | Result | Cabib C, Ortega O, Kumru H, Palomeras E, Vilardell N, Alvarez-Berdugo D, Muriana D, Rofes L, Terre R, Mearin F, Clave P. Neurorehabilitation strategies for poststroke oropharyngeal dysphagia: from compensation to the recovery of swallowing function. Ann N Y Acad Sci. 2016 Sep;1380(1):121-138. doi: 10.1111/nyas.13135. Epub 2016 Jul 11. |
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There is no plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C008922 | piperine |
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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2 days randomized crossover study with 60 patients in 3 treatment groups:
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Blinding will be applicable for clinical and instrumental assessments for investigators, and for intervention condition for patients.
tDCS will be applied for 20 minutes at 2.0 mA with the anode electrode positioned over the pharyngeal primary motor cortex (M1) of the unaffected hemisphere (3.5 cm lateral / 1 cm anterior to the vertex) and the cathode over the opposite supraorbital region. During central stimulation, 5 ml of capsaicin (10 μM) will be administered orally every 5 min. After each administration, the patient will be asked to perform dry swallows every minute. In order to avoid alterations in the safety and efficacy of swallowing during the procedure, the bolus will be rheologically adapted according to the patient's requirements. Crossover study, each arm includes a placebo + sham stimulation in one of the two days of treatment. Patients will initiate either placebo + sham stimulation or capsaicin + tDCS randomly in the first or second day depending on the randomization. |
|
| Piperine 1mM + tDCS 2mA | Combination Product | 2 days treatment with either sham + placebo or piperine 1mM + tDCS 2mA (cross-over randomized study). |
|
| Capsaicin 10μM + tDCS 2mA | Combination Product | 2 days treatment with either sham + placebo or capsaicin 10μM + tDCS 2mA (cross-over randomized study). |
|
| Baseline and 3 months follow-up visits. |
| Bioimpedance | Bioimpedance parameters (total body water, extracellular water, intracellular water, phase angle, muscle mass and cell mass) | Day 1, +24 hours, and at 3 months follow-up. |
| Blood analysis | Analytical parameters (albumin, pre-albumin, total protein, total lymphocytes and total cholesterol). | Baseline and 3 months follow-up visits. |
| Neuropeptides in saliva determination | Determination by ELISA of concentration of the neuropeptides substance P and CGRP (Calcitonin gene-related peptide) in saliva sample. | Day 1, +24 hours, and at 3 months follow-up. |
| Length of hospital stay | length of stay during the study. | From baseline to the end of the study (3-months follow-up visit). |
| Aspiration pneumonia admissions | Aspiration pneumonia admissions during the study period. | From baseline to the end of the study (3-months follow-up visit). |
| General hospital readmissions | General hospital readmissions by any cause during the study period. | From baseline to the end of the study (3-months follow-up visit). |
| Mortality over the study period | Mortality over the study period. | From baseline to the end of the study (3-months follow-up visit). |
| Safety of the treatment | Safety of the treatment applied (adverse events rate) during all the study period. | From baseline to the end of the study (3-months follow-up visit). |
| 21441148 | Result | Kumar S, Wagner CW, Frayne C, Zhu L, Selim M, Feng W, Schlaug G. Noninvasive brain stimulation may improve stroke-related dysphagia: a pilot study. Stroke. 2011 Apr;42(4):1035-40. doi: 10.1161/STROKEAHA.110.602128. Epub 2011 Mar 24. |
| 36142680 | Result | Tomsen N, Ortega O, Alvarez-Berdugo D, Rofes L, Clave P. A Comparative Study on the Effect of Acute Pharyngeal Stimulation with TRP Agonists on the Biomechanics and Neurophysiology of Swallow Response in Patients with Oropharyngeal Dysphagia. Int J Mol Sci. 2022 Sep 15;23(18):10773. doi: 10.3390/ijms231810773. |
| 30956054 | Result | Wang Z, Wu L, Fang Q, Shen M, Zhang L, Liu X. Effects of capsaicin on swallowing function in stroke patients with dysphagia: A randomized controlled trial. J Stroke Cerebrovasc Dis. 2019 Jun;28(6):1744-1751. doi: 10.1016/j.jstrokecerebrovasdis.2019.02.008. Epub 2019 Apr 5. |
| 24326980 | Result | Rofes L, Arreola V, Martin A, Clave P. Effect of oral piperine on the swallow response of patients with oropharyngeal dysphagia. J Gastroenterol. 2014 Dec;49(12):1517-23. doi: 10.1007/s00535-013-0920-0. Epub 2013 Dec 11. |
| 33799960 | Result | Nascimento W, Tomsen N, Acedo S, Campos-Alcantara C, Cabib C, Alvarez-Larruy M, Clave P. Effect of Aging, Gender and Sensory Stimulation of TRPV1 Receptors with Capsaicin on Spontaneous Swallowing Frequency in Patients with Oropharyngeal Dysphagia: A Proof-of-Concept Study. Diagnostics (Basel). 2021 Mar 7;11(3):461. doi: 10.3390/diagnostics11030461. |
| 35460440 | Result | Alvarez-Larruy M, Tomsen N, Guanyabens N, Palomeras E, Clave P, Nascimento W. Spontaneous Swallowing Frequency in Post-Stroke Patients with and Without Oropharyngeal Dysphagia: An Observational Study. Dysphagia. 2023 Feb;38(1):200-210. doi: 10.1007/s00455-022-10451-3. Epub 2022 Apr 23. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |