Acute Stroke, Dysphagia
Conditions
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.
Interventions
DEVICEtranscranial 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.
Sponsors
Université Catholique de Louvain
University Hospital of Mont-Godinne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
randomisation by computer
Intervention model description
tDCS
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VideoFluoroscopy (VFSS) | baseline, end of acute stroke phase, follow up (3, 6, 12 months) | 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 |
| Fiberoptic Endoscopic Evaluation of Swallowing (FEES) | baseline, end of acute stroke phase, follow up (3, 6, 12 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIH Stroke Scale | baseline, end of acute stroke phase, follow up (3, 6, 12 months) | The NIS Stroke Scale is a clinical scale developped to score the severity of acute stroke. Patients will be asked to make some movements, vision will be tested, whether there are difficult to speak and so on. |
| clinical record | baseline, end of acute stroke phase, follow up (3, 6, 12 months) | the records of the acute stroke patients will be used to search for relevant clinical events. |
| quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL) | baseline, end of acute stroke phase, follow up (3, 6, 12 months) | A quality-of-life (QOL) questionnaire specifically designed for patients with oropharyngeal dysphagia (SWAL-QOL) will be used, questions will be asked to the patients / proxies? The French version of the SWAL-QOL will be used |
Countries
Belgium
Outcome results
None listed