title: 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: OBJECTIVE
  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.
authors.affiliation: Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.
authors.forename: Sarah
authors.initials: S
authors.lastname: Marchina
authors.affiliation: Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.
authors.forename: Gottfried
authors.initials: G
authors.lastname: Schlaug
authors.affiliation: Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts. Electronic address: skumar@bidmc.harvard.edu.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Kumar
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001900:Boston; D002985:Clinical Protocols; D003679:Deglutition; D003680:Deglutition Disorders / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000534:rehabilitation*; D004185:Disability Evaluation; D004311:Double-Blind Method; D004435:Eating; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology; D000071939:Stroke Rehabilitation; D062606:Tertiary Care Centers; D013997:Time Factors; D065908:Transcranial Direct Current Stimulation / Q000009:adverse effects / Q000401:mortality; D016896:Treatment Outcome; D055815:Young Adult
keywords: Dysphagia; acute stroke; recovery; rehabilitation; tDCS; treatment