- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758991
Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation (iSWAT)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Namur
-
Yvoir, Namur, Belgium, 5530
- University Hospital of Mont-Godinne : CHU Mont-Godinne UCL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 |
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.
Other Names:
|
Placebo Comparator: 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)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VideoFluoroscopy (VFSS)
Time Frame: 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
|
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
|
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Time Frame: 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. |
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NIH Stroke Scale
Time Frame: 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.
|
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
|
clinical record
Time Frame: 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.
|
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
|
quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL)
Time Frame: 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
|
baseline, end of acute stroke phase, follow up (3, 6, 12 months)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B039201111926
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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