Clinical trial NCT01758991: Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation
Official title: Therapeutic Impact of tDCS on Dysphagia in the Acute Phase of Stroke / Impact thérapeutique de la tDCS Sur la Dysphagie en Phase Aigue de l'Accident Vasculaire cérébral
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Stroke
Dysphagia
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
First posted: 2013-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: tDCS
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: VideoFluoroscopy (VFSS)
timeFrame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
measure: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
timeFrame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
Secondary outcomes:
measure: NIH Stroke Scale
timeFrame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
measure: clinical record
timeFrame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
measure: quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL)
timeFrame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: University Hospital of Mont-Godinne : CHU Mont-Godinne UCL
state: Namur
Study officials:
affiliation: University Hospital of Mont-Godinne
name: Yves Vandermeeren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: