An interventional study of transcranial direct current stimulation (tDCS) in Acute Stroke and Dysphagia, sponsored by University Hospital of Mont-Godinne. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University Hospital of Mont-Godinne · Not applicable, Interventional, and Treatment
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.
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University Hospital of Mont-Godinne is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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)
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.
Also known as: Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany
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
Time frame: 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.
Time frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
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.
Time frame: 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.
Time frame: 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
Time frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital of Mont-Godinne