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

Not Applicable

Recruiting

Conditions: R13.0

Registration Number: DRKS00016845

Lead Sponsor: Schön Klinik Bad Aibling

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 82

Inclusion Criteria

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

Exclusion Criteria

-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
-epilepsy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of the Penetration-Aspiration scale (PAS; Rosenbek et al. 1996) for the consistencies saliva, water and puree determinded by flexible endoscopic Evaluation of swallowing (FEES) at baseline and at one week post stimulation.

Secondary Outcome Measures

Name	Time	Method
-Yale Residue Scale (Neubauer et al. 2015)<br>-Bogenhausener Dysphagie-scales (BODS1 und BODS2) (Bartolome et al. 2018)<br>-Functional Oral Intake Scale (FOIS) (Crary et al. 2005)<br>-Dysphagia Severity Rating Scale (DSRS) (Jayasekeran et al. 2010)<br>-swallowing frequency during 5 minutes (tactile measurement)<br>-National Institute of Health Stroke Scale (NIHSS)<br>-Barthel Index<br>-Box-Block-Test<br>-Test of Attentional Performance (TAP), Untertest Alertness<br>-Test of Attentional Performance (TAP), Untertest Go/ NoGo<br><br>Timeline for measurements: baseline, 1 week post stimulation, 3 weeks post stimulation (BODS1, BODS 2, DSRS, FOIS, swallowing frequency, Barthel Index)