Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation (iSWAT)

University Hospital of Mont-Godinne

Status: Terminated

Conditions: Dysphagia; Acute Stroke

Treatments: Device: transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01758991

B039201111926

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

real tDCS

Active Comparator group

Description:

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

Treatment:

Device: transcranial direct current stimulation (tDCS)

sham tDCS

Placebo Comparator group

Description:

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)

Treatment:

Device: transcranial direct current stimulation (tDCS)