Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation

Not Applicable

Terminated

• Conditions: Acute Stroke; Dysphagia
• Interventions: Device: transcranial direct current stimulation (tDCS)

• Registration Number: NCT01758991
• Lead Sponsor: University Hospital of Mont-Godinne

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-12-27
• Study First Submitted QC: 2012-12-27
• Study Start: 2013-01
• Study First Posted: 2013-01-01
• Status Verified: 2023-05
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real tDCS	transcranial direct current stimulation (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
sham tDCS	transcranial direct current stimulation (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)

Primary Outcome Measures

Name	Time	Method
VideoFluoroscopy (VFSS)	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)	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

Name	Time	Method
NIH Stroke Scale	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	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)	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

Trial Locations

Locations (1)

University Hospital of Mont-Godinne : CHU Mont-Godinne UCL; 🇧🇪 Yvoir, Namur, Belgium