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Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation (iSWAT)

This study is currently recruiting participants.
Verified October 2016 by Yves Vandermeeren, University Hospital of Mont-Godinne
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758991
First Posted: January 1, 2013
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Université Catholique de Louvain
Information provided by (Responsible Party):
Yves Vandermeeren, University Hospital of Mont-Godinne
  Purpose

In the acute phase of stroke, dysphagia (difficulty/inability to swallow) is a common problem that can have serious consequences such as aspiration pneumonia, increased lenght of hospitalisation, and death. It would be interesting to enhance the therapeutic effect of swallowing retraining by means on non-invasive brain stimulation such as transcranial direct current stimulation (tDCS).

Hypothesis: during the acute phase of stroke, applying tDCS over the brain during the revalidation and/or supervised feeding improves dysphagia significantly when compared to sham tDCS.


Condition Intervention Phase
Acute Stroke Dysphagia Device: transcranial direct current stimulation (tDCS) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Impact of tDCS on Dysphagia in the Acute Phase of Stroke / Impact thérapeutique de la tDCS Sur la Dysphagie en Phase Aigue de l'Accident Vasculaire cérébral

Resource links provided by NLM:


Further study details as provided by Yves Vandermeeren, University Hospital of Mont-Godinne:

Primary Outcome Measures:
  • VideoFluoroscopy (VFSS) [ Time Frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months) ]
    The patients will be asked to swallow radiocontrast agent liquid during RX (radiography) video-recording. The speed of swallowing, whether there is aspiration or stasis will be quantified off-line on videotape

  • Fiberoptic Endoscopic Evaluation of Swallowing (FEES) [ Time Frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months) ]

    A laryngoscope (attached to a camera and a color monitor) will be passed through the nostril.

    The patients will be asked to swallow small quantities of liquids and foods, and the quality of swallowing will be assessed off-line (videotaped examination).

    The base of the tongue, pharynx and larynx will be viewed.



Secondary Outcome Measures:
  • NIH Stroke Scale [ Time Frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months) ]
    The NIS Stroke Scale is a clinical scale developped to score the severity of acute stroke. Patients will be asked to make some movements, vision will be tested, whether there are difficult to speak and so on.

  • clinical record [ Time Frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months) ]
    the records of the acute stroke patients will be used to search for relevant clinical events.

  • quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL) [ Time Frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months) ]
    A quality-of-life (QOL) questionnaire specifically designed for patients with oropharyngeal dysphagia (SWAL-QOL) will be used, questions will be asked to the patients / proxies? The French version of the SWAL-QOL will be used


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: real tDCS

patients will receive non-invasive and painless brain stimulation over the rain areas involved in swallowing.

tDCS will be applied during swallowing therapy, during 20 minutes

Device: transcranial direct current stimulation (tDCS)
tDCS is a safe and painless transcranial stimulation that modulates brain activity and could improve stroke recovery. Electrodes in soaked sponges are placed over specific brain regions and held with an elastic band. Direct current is then applied through the electrodes. The patients may feel nothing or a slight tingling under the electrodes.
Other Name: Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany
Placebo Comparator: sham tDCS
this will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial)
Device: transcranial direct current stimulation (tDCS)
tDCS is a safe and painless transcranial stimulation that modulates brain activity and could improve stroke recovery. Electrodes in soaked sponges are placed over specific brain regions and held with an elastic band. Direct current is then applied through the electrodes. The patients may feel nothing or a slight tingling under the electrodes.
Other Name: Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany

Detailed Description:

tDCS will be used in a double-blind, randomized control trial in acute stroke patients suffering from dysphagia.

After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during swallowing exercices/therapy or supervised feeding.

Baseline and follow-up outcomes about dysphagia will be collected.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- acute stroke (ischemic / hemorrhagic) with dysphagia

Exclusion Criteria:

  • major swallowing impairment before the stroke
  • troubles of comprehension impairing communication
  • major cognitive dysfunction, neuro-degenerative disease, or major psychiatric condition (e.g. depression, Alzheimer's disease, …)
  • very unstable health issue (e.g. severe cardiac dyscfct, end-stage renal failure, unstable diabetes, …)
  • intracranial metal and/or devices excluding tDCS application
  • chronic intake of major drugs modifying brain activity (e.g. AEDs, antipsychotics)
  • regular use of alcohol or recreative drugs
  • epilepsy
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758991


Contacts
Contact: Katalin de Fays, MSc +32 81 42 33 39 katalin.defays@uclouvain.be

Locations
Belgium
University Hospital of Mont-Godinne : CHU Mont-Godinne UCL Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Katalin de Fays, MSc    +3281423348    katalin.defays@uclouvain.be   
Sponsors and Collaborators
University Hospital of Mont-Godinne
Université Catholique de Louvain
Investigators
Principal Investigator: Yves Vandermeeren, MD, PhD University Hospital of Mont-Godinne
  More Information

Additional Information:
Responsible Party: Yves Vandermeeren, Professor (MD, PhD), University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT01758991     History of Changes
Other Study ID Numbers: B039201111926
First Submitted: December 27, 2012
First Posted: January 1, 2013
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Stroke
Deglutition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases