Pharyngeal electrical stimulation in patients with neurogenic dysphagia not responding to standard therapy (PES-NOREST): double blind, randomized clinical trial of efficacy. - PES-NOREST

Schön Klinik Bad Aibling0 个研究点目标入组 82 人开始时间: 2019年3月4日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•ischemic or hemorrhagic stroke
•-one-time monohemispheric lesion
•-positive standardized aspiration screening (modified Evan´s Blue Dye Test (Belafsky et al., 2003); TOR-BSST (Martino et al. 2009))
•-Bogenhausener Dysphagie Score 2 (oral diet) =5
•-Functional oral intake scale (Crary et al. 2005) FOIS =3
•-need for feeding tube or intravenous Infusion
•-Need for feeding tube + PAS =6 persist 4 weeks post onset
•-Patient received a minimum of 8 units traditional dysphagia therapy
•-endoscopically proven aspiration (Penetration-Aspiration Scale PAS =6) for at least one consistency
•-inpatient at Schön Klinik Bad Aibling

•-no informed consent
•-pre-existing dysphagia
•-cardiac pacemaker
•-implanted defibrillator
•-continuous need for oxygen
•-pre-existing neurologic or morphologic-anatomic lesions
•-brainstem or cerebellar lesion
•-2nd motor neuron n. recurrens lesion
•-insufficient refelctory cough
•-oro-pharyngo-esophageal tumors
•-severe non-substitutional coagulation deficits
•-partial respiratory insufficiency (Sa02 < 90%)
•-bradycardia < 50/min
•-pregnancy
•-simultaneous inclusion in another clinical trial
•-delay between FEES at baseline and study inclusion < 7 days
•-metallic or electronic cerebral implants
•-skin lesions in the region of stimulation, mainly eczema, psoriasis, dermatitis

发起方