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.
- Transcranial direct current stimulation (tDCS) Device
Other Names: tDCS; Low intensity transcranial DC stimulator; Soterix 1x1 Intervention Desc: 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. ARM 1: Kind: Experimental Label: real tDCS Description: 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 ARM 2: Kind: Experimental Label: sham tDCS Description: 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)
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||VideoFluoroscopy (VFSS)||baseline, end of acute stroke phase, follow up (3, 6, 12 months)||No|
|Primary||Fiberoptic Endoscopic Evaluation of Swallowing (FEES)||baseline, end of acute stroke phase, follow up (3, 6, 12 months)||No|
|Secondary||NIH Stroke Scale||baseline, end of acute stroke phase, follow up (3, 6, 12 months)||No|
|Secondary||clinical record||baseline, end of acute stroke phase, follow up (3, 6, 12 months)||No|
|Secondary||quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL)||baseline, end of acute stroke phase, follow up (3, 6, 12 months)||No|