Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation

NCT ID: NCT01758991

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2023-05-08

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.

Detailed Description

tDCS will be used in a double-blind, randomized control trial in acute stroke patients suffering from dysphagia.

After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during swallowing exercices/therapy or supervised feeding.

Baseline and follow-up outcomes about dysphagia will be collected.

Conditions

Acute Stroke; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

real tDCS

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

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type: 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.

sham tDCS

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)

Group Type: PLACEBO_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type: 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.

Interventions

transcranial direct current stimulation (tDCS)

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.

Intervention Type: DEVICE

Other Intervention Names

Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany

Eligibility Criteria

Inclusion Criteria

• acute stroke (ischemic / hemorrhagic) with dysphagia

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

University Hospital of Mont-Godinne

OTHER

Sponsor Role: lead

Responsible Party

Pr Yves Vandermeeren, MD, PhD

Professor (MD, PhD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yves Vandermeeren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Mont-Godinne

Locations

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

Yvoir, Namur, Belgium

Countries

Belgium

Other Identifiers

B039201111926

Identifier Type: -

Identifier Source: org_study_id