Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation "iSWAT"

Recruiting

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Transcranial direct current stimulation (tDCS) Device
    Other Names: tDCS; Brain Stimulation
    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)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors