R13.0
Conditions
Interventions
Group 1: Pharyngeal electrical stimulation
5 stimulation sessions for 10 minutes each
intensity: 75% of tolerance level
1h post stimulation: traditional dysphagia therapy
Group 2: Transcranial direct current stimulation: 5 anodal stimulation sessions over the healthy hemisphere for 10 minutes each
intensity: 1.5 mA
1 h post stimulation: traditional dysphagia therapy
Group 3: Sham: 50% PES, 50% tdcs
5 sessions for 10 minutes each
intensity 0 mA
1 h post sham stimulation: traditional dysphagia therapy
Sponsors
Schön Klinik Bad Aibling
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| -Yale Residue Scale (Neubauer et al. 2015) -Bogenhausener Dysphagie-scales (BODS1 und BODS2) (Bartolome et al. 2018) -Functional Oral Intake Scale (FOIS) (Crary et al. 2005) -Dysphagia Severity Rating Scale (DSRS) (Jayasekeran et al. 2010) -swallowing frequency during 5 minutes (tactile measurement) -National Institute of Health Stroke Scale (NIHSS) -Barthel Index -Box-Block-Test -Test of Attentional Performance (TAP), Untertest Alertness -Test of Attentional Performance (TAP), Untertest Go/ NoGo Timeline for measurements: baseline, 1 week post stimulation, 3 weeks post stimulation (BODS1, BODS 2, DSRS, FOIS, swallowing frequency, Barthel Index) | — |
Countries
Germany
Contacts
Public ContactFriedemann Müller
Schön Klinik Bad Aibling
Outcome results
None listed