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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital of Mont-Godinne
Sponsor:
Collaborator:
Université catholique de Louvain (UCL), Institute of NeuroScience (IoNS)
Information provided by (Responsible Party):
Yves Vandermeeren, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier:
NCT01758991
First received: December 27, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University Hospital of Mont-Godinne:

Primary Outcome Measures:
  • VideoFluoroscopy (VFSS) [ Time Frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758991

Contacts
Contact: Katalin de Fays, BSc +32 81 42 33 48 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 (UCL), Institute of NeuroScience (IoNS)
Investigators
Principal Investigator: Yves Vandermeeren, MD, PhD University Hospital of Mont-Godinne
  More Information

Additional Information:
No publications provided

Responsible Party: Yves Vandermeeren, Professor (MD, PhD), University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT01758991     History of Changes
Other Study ID Numbers: B039201111926
Study First Received: December 27, 2012
Last Updated: December 27, 2012
Health Authority: Belgium: Ethics Committee
Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014