tDCS for Dysphagia Associated to Brainstem Stroke

NCT04308733 | Unknown

• 1 other identifier: Restivo Domenico
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Oral Intake Scale (FOIS)

  Change from baseline FOIS at 4 days

• Dysphagia Limit Test

  Change from baseline "Dysphagia Limit Test" at 4 days

• Pharyngeal (motor evoked potentials (MEPs) after Transcranial Magnetic Stimulation (TMS)

  Change from baseline pharyngeal MEPs at 4 days

• electromyographic/cinematic evaluation of swallowing

  Change from baseline electromyographic/cinematic parameters at 4 days

Study Arms (2)

real tDCS

ACTIVE COMPARATOR

30 patients will be treated with real anodal tDCS over the contralateral pharyngeal motor cortex

Device: Anodal tDCS

sham tDCS

SHAM COMPARATOR

30 patients will be treated with sham tDCS over the contralateral pharyngeal motor cortex

Device: Anodal tDCS

Interventions

Anodal tDCS DEVICE

patients will be stimulated over the contralateral pharyngeal motor cortex with anodal tDCS (2mA, 20 minutes) for 4 consecutive days

real tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Presidio Ospedaliero Garibaldi-Centro: lead

Study Sites (1)

Domenico A. Restivo

Catania, 95100, Italy

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Domenico A Restivo, MD, PhD

CONTACT

+39 095 7593909; darestivo@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consutant Neurologist

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 16, 2020
• Study Start: March 30, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

IT (1)