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

May 8, 2023 updated by: Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Namur
      • Yvoir, Namur, Belgium, 5530
        • University Hospital of Mont-Godinne : CHU Mont-Godinne UCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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 Names:
  • 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)
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 Names:
  • Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
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.

baseline, end of acute stroke phase, follow up (3, 6, 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
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.
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
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
baseline, end of acute stroke phase, follow up (3, 6, 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

December 27, 2012

First Submitted That Met QC Criteria

December 27, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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