Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Stroke, Dysphagia

Intervention / Treatment
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* Device: transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: tDCS
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: real tDCS<br>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)<br>* 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.<br>* Other names: Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany;|
| Placebo Comparator: sham tDCS<br>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)<br>* 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.<br>* Other names: Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VideoFluoroscopy (VFSS) | 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) | 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 | 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 | 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) | 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) |