Trial document




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  DRKS00016845

Trial Description

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Title

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

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Trial Acronym

PES-NOREST

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study investigates whether pharyngeal electrical stimulation (PES) or transcranial direct current stimulation of the brain (tdcs) can improve the restoration of swallowing function after hemispheric stroke.
The aims of the study are to reduce the risk of penetration-aspiration and to allow safe oral diet and drinking.
It is hypothesized that both forms of electrical stimulation will improve the safety of swallowing and will lead to a reduction of penetration-aspiration. We will include postacute and chronic dysphagic patients suffering from a one-time monohemispheric stroke who depend on a feeding tube four weeks post onset. Patients will receive either PES, tdcs or sham stimulation.

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Brief Summary in Scientific Language

1. Scientific background: The effectiveness of neuromodulative techniques like pharyngeal electrical Stimulation (PES) or transcranial direct current Stimulation (tdcs) has mainly been investigated in acute but to a much lesser extent in postacute and chronic dysphagic patients. Preliminary studies in our own institution indicate that functional improvements can be induced through neuromodulative techniques in postacute and chronic dysphagic patients even if they are non-responders to traditional swallowing therapies. An observative analysis of 151 chronic dysphagic patients could demonstrate a significant improvement of functional parameters for oral diet and tracheostomy tubes after PES (Ledl 2015). In a next step, a randomized-controlled study needs to be done in order to establish a reliable scientific proof of effectiveness of PES and/ or tdcs in subacute and chronic dysphagia.
2. Aim: to investigate the efficency of PES and tdcs in subacute and chronic neurogenic dysphagia.
3. Method: monocentric stratified (patients with and without tracheostomy tube in a 2:1 realtion) bouble-blind study with parallel groups. One active group will receive real pharyngeal electrical stimulation, another active group will receive real tdcs, the control-group will receive sham PES or sham tdcs.
4. Clinical relevance: PES and tdcs are applied only in specialized centres and are rarely used in standard care so that the number of possibly undertreated postacute and chronic dysphagic patients is presumably high. It is expected that studies on functional benefit of PES and tdcs will lead to a reevaluation of therapeutical options in the treatment of postacute and chronic dysphagic patients.

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Organizational Data

  •   DRKS00016845
  •   2019/03/04
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  •   yes
  •   Approved
  •   17-706 fed, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   R13.0 -  [generalization R13: Dysphagia]
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Interventions/Observational Groups

  •   Pharyngeal electrical stimulation; 5 stimulation sessions for 10 minutes each; intensity: 75% of tolerance level; 1h post stimulation: traditional dysphagia therapy;
  •   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;
  •   Sham: 50% PES, 50% tdcs; 5 sessions for 10 minutes each; intensity 0 mA; 1 h post sham stimulation: traditional dysphagia therapy;
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

-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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/04/03
  •   82
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Schön Klinik Bad Aibling
    • Mr.  Christian  Ledl 
    • Kolbermoorer Str. 72
    • 83043  Bad Aibling
    • Germany
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    • Neurologische Klinik und Poliklinik der Universität München Großhadern
    • Mr.  Prof. Dr. med.  Andreas  Straube 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Schön Klinik Bad Aibling
    • Mr.  Christian  Ledl 
    • Kolbermoorer Str. 72
    • 83043  Bad Aibling
    • Germany
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    • Schön Klinik Bad Aibling
    • Mr.  Dr.  Friedemann  Müller 
    • Kolbermoorer Str. 72
    • 83043  Bad Aibling
    • Germany
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Sources of Monetary or Material Support

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    • Schön Klinik Bad Aibling
    • Mr.  Prof. Dr. med.  Klaus  Jahn 
    • Kolbermoorer Str. 72
    • 83043  Bad Aibling
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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