Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation

Dysphagia Clinical Trial

— iSWAT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01758991
• Other study ID #: B039201111926
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: University Hospital of Mont-Godinne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital of Mont-Godinne : CHU Mont-Godinne UCL	Yvoir	Namur

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne	Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	NIH Stroke Scale	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.	baseline, end of acute stroke phase, follow up (3, 6, 12 months)
Secondary	clinical record	the records of the acute stroke patients will be used to search for relevant clinical events.	baseline, end of acute stroke phase, follow up (3, 6, 12 months)
Secondary	quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL)	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	baseline, end of acute stroke phase, follow up (3, 6, 12 months)