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

Primary Purpose

Acute Stroke, Dysphagia

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

transcranial direct current stimulation (tDCS)

About this trial

This is an interventional treatment trial for Acute Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University Hospital of Mont-Godinne : CHU Mont-Godinne UCL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

real tDCS

sham tDCS

Arm 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

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)

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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.

clinical record

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)

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

Full Information

NCT ID

NCT01758991

First Posted

December 27, 2012

Last Updated

May 8, 2023

Sponsor

University Hospital of Mont-Godinne

Collaborators

Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT01758991

Brief Title

Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

lack of recruitment

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 8, 2023 (Actual)

Study Completion Date

May 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Mont-Godinne

Collaborators

Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke, Dysphagia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

tDCS

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

randomisation by computer

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

real tDCS

Arm Type

Active Comparator

Arm 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

Arm Title

sham tDCS

Arm Type

Placebo Comparator

Arm 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)

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation (tDCS)

Other Intervention Name(s)

Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany

Intervention Description

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.

Primary Outcome Measure Information:

Title

VideoFluoroscopy (VFSS)

Description

Time Frame