tDCS for Dysphagia Associated to Brainstem Stroke

Transcranial Direct Current Stimulation (tDCS) for Patients With Oro-pharyngeal Dysphagia Associated to Brainstem Stroke

The aim of the study is to investigate the effect of anodal transcranial direct current stimulation applied over the pharyngeal motor area in 60 dysphagic patients with acute isolated brainstem stroke. Thirty patients will undergo stimulation on the pharyngeal area contralateral to the side of brainstem lesion, and 30 patients will receive sham stimulation over the contralateral area, for 4 consecutive days. Patients will be re-evaluated after 4 consecutive days of stimulation. Primary outcome: The Penetration/Aspiration Scale after 4 consecutive days of stimulation. Secondary outcomes: changes in electromyographic parameters and pharyngeal cortical motor evoked potentials, changes in the Dysphagia Severity Rating Scale (DSRS), in the Functional Oral Intake Scale (FOIS), and in the "Dysphagia Limit Test", after 4 consecutive days of stimulation.

Study Overview

• Status: Unknown
• Conditions: Dysphagia
• Intervention / Treatment: Device: Anodal tDCS

Detailed Description

Sixty consecutive patients with dysphagia associated to isolated acute (within the previous 24 hours) brainstem ischemic stroke satisfying the inclusion/exclusion criteria will be enrolled.

Swallowing evaluation Clinical evaluation comprises fiberoptic endoscopy that will be used for scoring the Penetration/Aspiration Scale. The Penetration/Aspiration Scale will be scored by two otolaryngologists and one neurologist blinded to the patient's study group allocation. Moreover, feeding status will be evaluated by the clinical "Dysphagia Severity Rating Scale", ranging from 0 (normal fluids, normal diet, and eating independently) to 12 (no oral fluids, no oral feeding). Moreover the "Functional Oral Intake Scale", ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction), and the "Dysphagia Limit Test", evaluating the amount of water that can be swallowed without piece-meal deglutition or clinical signs of aspiration, will be used in patient evaluation. Piecemeal deglutition will be evaluated both clinically and by means of electromyographic recordings from the mouth floor muscles. Moreover, simultaneous electromyographic/mechanographic recordings from the above mentioned muscles, as well as from cricopharyngeal muscle and from the thyroid cartilage will be also performed. The changes in cortico-pharyngeal excitability will be evaluated by recording motor evoked potentials from the pharyngeal muscles after transcranial magnetic stimulation.

Randomization: patients will be randomly assigned to either the active treatment (real) or sham groups according to a computer-generated list. Randomization will be stratified in order to match age, and severity of dysphagia.

Transcranial direct current stimulation: anodal transcranial direct current stimulation will be delivered through two 25-cm2 rectangular surface electrodes, with the active one placed over the "pharyngeal" area of the motor cortex contralateral to the side of brainstem lesion and the reference one on the contralateral supraorbital ridge. Furthermore, the electrodes will be fixed in their position using a set of adjustable rubber straps placed around the head. For the active intervention (the "real" stimulation group), current intensity will be slowly increased up to 2mA. This intensity will be maintained for 20 min before the stimulation will be slowly turned off over a 10-sec period. For the "sham" intervention, the current will be left on only for 30 sec, while the electrodes will be left in place for a further 20-min period. All patients will be evaluated at baseline, and after 4 consecutive days of stimulation.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95100
    • Recruiting
    • Domenico A. Restivo
    • Contact: Domenico A Restivo, MD, PhD; Phone Number: +39 095 7593909; Email: darestivo@libero.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• accepting to participating to the study
• age not < 18 years
• bulbar stroke occurring within the previous 24 hours

Exclusion Criteria:

• age < 18 years
• inability to give informed consent because of cognitive impairment
• stroke occurring over the previous 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: real tDCS; 30 patients will be treated with real anodal tDCS over the contralateral pharyngeal motor cortex	Device: Anodal tDCS; patients will be stimulated over the contralateral pharyngeal motor cortex with anodal tDCS (2mA, 20 minutes) for 4 consecutive days
Sham Comparator: sham tDCS; 30 patients will be treated with sham tDCS over the contralateral pharyngeal motor cortex	Device: Anodal tDCS; patients will be stimulated over the contralateral pharyngeal motor cortex with anodal tDCS (2mA, 20 minutes) for 4 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration Aspiration Scale (PAS)	PAS is an 8-point severity scale from 1 = no material enters the airways to 8 = material enters the airways, passes below the vocal folds in the absence of any effort to eject it.	Change from baseline PAS at 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Oral Intake Scale (FOIS)	FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction)	Change from baseline FOIS at 4 days
Dysphagia Limit Test	The "Dysphagia Limit Test", evaluates the amount of water that can be swallowed without piece-meal deglutition or clinical signs of aspiration.	Change from baseline "Dysphagia Limit Test" at 4 days
Pharyngeal (motor evoked potentials (MEPs) after Transcranial Magnetic Stimulation (TMS)	the changes in amplitude of MEPs recorded from pharyngeal muscle after TMS over the pharyngeal contralateral motor cortex will be evaluated	Change from baseline pharyngeal MEPs at 4 days
electromyographic/cinematic evaluation of swallowing	Simultaneous electromyographic/cinematic recordings from mouth floor muscles, cricopharyngeal muscle and thyroid cartilage will be performed	Change from baseline electromyographic/cinematic parameters at 4 days

Collaborators and Investigators

• Sponsor: Presidio Ospedaliero Garibaldi-Centro

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Brain Ischemia; Esophageal Diseases; Infarction; Stroke; Brain Infarction; Deglutition Disorders; Brain Stem Infarctions
• Other Study ID Numbers: Restivo Domenico

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No