Stroke Clinical Trial
— ICI20/00117Official title:
Treatment of Chronic Post-stroke Oropharyngeal Dysphagia With Paired Stimulation Through Peripheral TRVP1 Agonists and Non-invasive Brain Stimulation
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Mataró. Consorci Sanitari del Mareme. | Mataró | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital de Mataró | Consorci Sanitari del Maresme, Instituto de Salud Carlos III |
Spain,
Cabib C, Nascimento W, Rofes L, Arreola V, Tomsen N, Mundet L, Muriana D, Palomeras E, Michou E, Clave P, Ortega O. Neurophysiological and Biomechanical Evaluation of the Mechanisms Which Impair Safety of Swallow in Chronic Post-stroke Patients. Transl St — View Citation
Cabib C, Nascimento W, Rofes L, Arreola V, Tomsen N, Mundet L, Palomeras E, Michou E, Clave P, Ortega O. Short-term neurophysiological effects of sensory pathway neurorehabilitation strategies on chronic poststroke oropharyngeal dysphagia. Neurogastroente — View Citation
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 — View Citation
Cabib C, Ortega O, Vilardell N, Mundet L, Clave P, Rofes L. Chronic post-stroke oropharyngeal dysphagia is associated with impaired cortical activation to pharyngeal sensory inputs. Eur J Neurol. 2017 Nov;24(11):1355-1362. doi: 10.1111/ene.13392. Epub 201 — View Citation
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. — View Citation
Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1. — View Citation
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. — View Citation
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 Proo — View Citation
Park JW, Oh JC, Lee JW, Yeo JS, Ryu KH. The effect of 5Hz high-frequency rTMS over contralesional pharyngeal motor cortex in post-stroke oropharyngeal dysphagia: a randomized controlled study. Neurogastroenterol Motil. 2013 Apr;25(4):324-e250. doi: 10.111 — View Citation
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 Sc — View Citation
Tomsen N, Ortega O, Rofes L, Arreola V, Martin A, Mundet L, Clave P. Acute and subacute effects of oropharyngeal sensory stimulation with TRPV1 agonists in older patients with oropharyngeal dysphagia: a biomechanical and neurophysiological randomized pilo — View Citation
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 — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the videofluoroscopy (signs of safety and efficacy of swallow) | Pre- vs post-intervention changes in:
- Frequency of videofluoroscopic (VFS) signs of safety and efficacy of swallow. |
5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Changes in the videofluoroscopy (Penetration-Aspiration scale) | Pre- vs post-intervention changes in:
- Penetration-Aspiration scale (PAS). The scales goes from 1 (safe swallow) to 8 (silent aspiration). The severity increases as the score increases. |
5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Timing of oropharyngeal swallow response (total deglutition time) with videofluoroscopy | - Total deglutition time (ms). | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Timing of oropharyngeal swallow response (time to laryngeal vestibule closure) with videofluoroscopy | - Time to laryngeal vestibule closure (ms). | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Timing of oropharyngeal swallow response (time to upper esophageal sphincter opening) with videofluoroscopy | - Time to upper esophageal sphincter opening (ms). | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Timing of oropharyngeal swallow response (bolus velocity) with videofluoroscopy | - Bolus velocity (m·s-1). | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Timing of oropharyngeal swallow response (Kinetic energy) with videofluoroscopy | - Kinetic energy of the bolus (mJ). | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Changes in neurophysiology of swallow (sensory pathway) latency | - Latency of pharyngeal sensory evoked potentials to intrapharyngeal electrical stimulation. | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Changes in neurophysiology of swallow (sensory pathway) amplitude | - Amplitude of pharyngeal sensory evoked potentials to intrapharyngeal electrical stimulation. | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Changes in neurophysiology of swallow (motor pathway) latency | - Latency of pharyngeal motor evoked potentials to transcranial magnetic stimulation. | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Primary | Changes in neurophysiology of swallow (motor pathway) amplitude | - Amplitude of pharyngeal motor evoked potentials to transcranial magnetic stimulation. | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Secondary | Changes in spontaneous swallowing frequency | Pre/post-intervention changes in spontaneous swallowing frequency (swallows/minute) | 5 days (changes between basal visit, time 0, and post-treatment visit, time + 5 days) | |
Secondary | Safety of the treatment | Safety of the treatment applied (adverse events rate) during all the study period. | Baseline (basal visit) to 3 months follow-up | |
Secondary | Length of stay | Length of hospital stay. | Baseline (basal visit) to 3 months follow-up | |
Secondary | Aspiration pneumonia admission | Admissions due to aspiration pneumonia during the study and at 3-month follow-up. | Baseline (basal visit) to 3 months follow-up | |
Secondary | Nutritional status | Nutritional status (MNA-sf) at baseline and at 3-month follow-up. | Baseline (basal visit) to 3 months follow-up | |
Secondary | Functional status | Functional status (Barthel index) at baseline and at 3-month follow-up. | Baseline (basal visit) to 3 months follow-up | |
Secondary | Functional status associated to stroke | Rankin scale at baseline and at 3-month follow-up. | Baseline (basal visit) to 3 months follow-up | |
Secondary | General hospital readmissions for any cause | Hospital readmissions during the study (from baseline (basal visit) to 3 months follow-up). | Baseline (basal visit) to 3 months follow-up | |
Secondary | Mortality | Mortality over the study period (from baseline (basal visit) to 3 months follow-up). | Baseline (basal visit) to 3 months follow-up | |
Secondary | Swallowing clinical evaluation | Volume-viscosity swallowing test (V-VST) parameters comparison between post-treatment visit (+5 days) and 3 months follow-up visit. | Immediately after the intervention to 3 months follow-up visit |
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