Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation

NCT01758991 | Terminated

• 1 other identifier: B039201111926
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In the acute phase of stroke, dysphagia (difficulty/inability to swallow) is a common problem that can have serious consequences such as aspiration pneumonia, increased lenght of hospitalisation, and death. It would be interesting to enhance the therapeutic effect of swallowing retraining by means on non-invasive brain stimulation such as transcranial direct current stimulation (tDCS). Hypothesis: during the acute phase of stroke, applying tDCS over the brain during the revalidation and/or supervised feeding improves dysphagia significantly when compared to sham tDCS.

Conditions

Acute Stroke; Dysphagia

Outcome Measures

Primary Outcomes (2)

• VideoFluoroscopy (VFSS)

  The patients will be asked to swallow radiocontrast agent liquid during RX (radiography) video-recording. The speed of swallowing, whether there is aspiration or stasis will be quantified off-line on videotape

  baseline, end of acute stroke phase, follow up (3, 6, 12 months)

• Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

  A laryngoscope (attached to a camera and a color monitor) will be passed through the nostril. The patients will be asked to swallow small quantities of liquids and foods, and the quality of swallowing will be assessed off-line (videotaped examination). The base of the tongue, pharynx and larynx will be viewed.

  baseline, end of acute stroke phase, follow up (3, 6, 12 months)

Secondary Outcomes (3)

• NIH Stroke Scale

  baseline, end of acute stroke phase, follow up (3, 6, 12 months)

• clinical record

  baseline, end of acute stroke phase, follow up (3, 6, 12 months)

• quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL)

  baseline, end of acute stroke phase, follow up (3, 6, 12 months)

Study Arms (2)

real tDCS

ACTIVE COMPARATOR

patients will receive non-invasive and painless brain stimulation over the rain areas involved in swallowing. tDCS will be applied during swallowing therapy, during 20 minutes

Device: transcranial direct current stimulation (tDCS)

sham tDCS

PLACEBO COMPARATOR

this will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial)

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

tDCS is a safe and painless transcranial stimulation that modulates brain activity and could improve stroke recovery. Electrodes in soaked sponges are placed over specific brain regions and held with an elastic band. Direct current is then applied through the electrodes. The patients may feel nothing or a slight tingling under the electrodes.

Also known as: Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany

real tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- acute stroke (ischemic / hemorrhagic) with dysphagia

You may not qualify if:

• major swallowing impairment before the stroke
• troubles of comprehension impairing communication
• major cognitive dysfunction, neuro-degenerative disease, or major psychiatric condition (e.g. depression, Alzheimer's disease, …)
• very unstable health issue (e.g. severe cardiac dyscfct, end-stage renal failure, unstable diabetes, …)
• intracranial metal and/or devices excluding tDCS application
• chronic intake of major drugs modifying brain activity (e.g. AEDs, antipsychotics)
• regular use of alcohol or recreative drugs
• epilepsy
• pregnancy

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead
• Université Catholique de Louvain: collaborator

Study Sites (1)

University Hospital of Mont-Godinne : CHU Mont-Godinne UCL

Yvoir, Namur, 5530, Belgium

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; 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

Study Officials

• Yves Vandermeeren, MD, PhD

  University Hospital of Mont-Godinne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomisation by computer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (MD, PhD)

Model Details: tDCS

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2013
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

BE (1)