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tDCS for Dysphagia Associated to Brainstem Stroke

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ClinicalTrials.gov Identifier: NCT04308733
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Domenico Antonio Restivo, Presidio Ospedaliero Garibaldi-Centro

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dysphagia Device: Anodal tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) for Patients With Oro-pharyngeal Dysphagia Associated to Brainstem Stroke
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Penetration Aspiration Scale (PAS) [ Time Frame: Change from baseline PAS at 4 days ]
    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.


Secondary Outcome Measures :
  1. Functional Oral Intake Scale (FOIS) [ Time Frame: Change from baseline FOIS at 4 days ]
    FOIS is a scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restriction)

  2. Dysphagia Limit Test [ Time Frame: Change from baseline "Dysphagia Limit Test" at 4 days ]
    The "Dysphagia Limit Test", evaluates the amount of water that can be swallowed without piece-meal deglutition or clinical signs of aspiration.

  3. Pharyngeal (motor evoked potentials (MEPs) after Transcranial Magnetic Stimulation (TMS) [ Time Frame: Change from baseline pharyngeal MEPs at 4 days ]
    the changes in amplitude of MEPs recorded from pharyngeal muscle after TMS over the pharyngeal contralateral motor cortex will be evaluated

  4. electromyographic/cinematic evaluation of swallowing [ Time Frame: Change from baseline electromyographic/cinematic parameters at 4 days ]
    Simultaneous electromyographic/cinematic recordings from mouth floor muscles, cricopharyngeal muscle and thyroid cartilage will be performed



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308733


Contacts
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Contact: Domenico A Restivo, MD, PhD +39 095 7593909 darestivo@libero.it

Locations
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Italy
Domenico A. Restivo Recruiting
Catania, Italy, 95100
Contact: Domenico A Restivo, MD, PhD    +39 095 7593909    darestivo@libero.it   
Sponsors and Collaborators
Presidio Ospedaliero Garibaldi-Centro
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Responsible Party: Domenico Antonio Restivo, Consutant Neurologist, Presidio Ospedaliero Garibaldi-Centro
ClinicalTrials.gov Identifier: NCT04308733    
Other Study ID Numbers: Restivo Domenico
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Brain Stem Infarctions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases