Study design for the fostering eating after stroke with transcranial direct current stimulation trial: a randomized controlled intervention for improving Dysphagia after acute ischemic stroke

Abstract

Goal: Dysphagia is a major stroke complication but lacks effective therapy that can promote recovery. Noninvasive brain stimulation with and without peripheral sensorimotor activities may be an attractive treatment option for swallowing recovery but has not been systematically investigated in the stroke population. This article describes the study design of the first prospective, single-center, double-blinded trial of anodal versus sham transcranial direct current stimulation (tDCS) used in combination with swallowing exercises in patients with dysphagia from an acute ischemic stroke. The aim of this study is to gather safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiologic and clinically relevant swallowing parameters, and examine possible dose effects.

Methods: Ninety-nine consecutive patients with dysphagia from an acute unilateral hemispheric infarction with a Penetration and Aspiration Scale (PAS) score of 4 or more and without other confounding reasons for dysphagia will be enrolled at a single tertiary care center. Subjects will be randomized to either a high or low dose tDCS or a sham group and will undergo 10 sessions over 5 consecutive days concomitantly with effortful swallowing maneuvers. The main efficacy measures are a change in the PAS score before and after treatment; the main safety measures are mortality, seizures, neurologic, motor, and swallowing deterioration.

Conclusions: The knowledge gained from this study will help plan a larger confirmatory trial for treating stroke-related dysphagia and advance our understanding of important covariates influencing swallowing recovery and response to the proposed intervention.

Trial registration: ClinicalTrials.gov NCT01919112.

Keywords: Dysphagia; acute stroke; recovery; rehabilitation; tDCS; treatment.

Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Trial Design Flowchart

Figure 2. Confirmation of electrode position with imaging

Co-registration of anode midposition between C3/T3 using 10–20 EEG systems with a T1-weighted dataset demonstrates it to be centered over the caudal end of the left primary motor cortex in a healthy volunteer. The position and dimensions of the anode depicted by the blue circle appears to completely cover the regions of maximal activation, depicted by colored dots, seen during swallowing tasks on fMRI across a group of healthy elderly volunteers.