Acute StrokeiSWATNCT01758991
Improving SWAllowing After Stroke With Transcranial Direct Current Stimulation
A study testing transcranial direct current stimulation (tDCS) in people with Acute Stroke and Dysphagia, run by University Hospital of Mont-Godinne at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke, Dysphagia
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to 8 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acute stroke (ischemic / hemorrhagic) with dysphagia
Who cannot join
- 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)
Show all 9Show fewer
- regular use of alcohol or recreative drugs
- epilepsy
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital of Mont-Godinne : CHU Mont-Godinne UCL
Yvoir, Namur, 5530
About this study
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
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.
Read the 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.
- Conditions
- Acute Stroke, Dysphagia
- Being tested
- transcranial direct current stimulation (tDCS)
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
Also called Eldith PLUS tDCS, NeuroConn, Ilmenau, Germany
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.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | 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 Receives: Device: transcranial direct current stimulation (tDCS) |
| sham tDCS | Placebo comparator | 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) Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
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.
Measured: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
Secondary outcomes (3)
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.
Measured: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
clinical record
the records of the acute stroke patients will be used to search for relevant clinical events.
Measured: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
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
Measured: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion8 May 2023
- Study completion8 May 2023
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- tDCS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Principal investigator, Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
- Investigators
- Yves Vandermeeren, MD, PhD, Principal investigator, University Hospital of Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758991
- Sponsor's protocol ID
- B039201111926
- Acronym
- iSWAT
- Status last verified
- May 2023
- First submitted
- 27 Dec 2012
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01758991
- Acronym / sponsor ID
- iSWAT / B039201111926
- Conditions
- Acute Stroke, Dysphagia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain
- Study start
- Jan 2013
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- tDCS
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: transcranial direct current stimulation (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 |
| sham tDCS | Placebo comparator | Device: transcranial direct current stimulation (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) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute stroke (ischemic / hemorrhagic) with dysphagia
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation (tDCS)Also: Eldith PLUS tDCS, NeuroConn, Ilmenau, GermanytDCS 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. | Device | real tDCS, sham tDCS |
Primary outcome
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
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.
3 secondary outcomes
NIH Stroke Scale
Time frame: 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)
quality-of-life (QOL) questionnaire designed for dysphagia (SWAL-QOL)
Time frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Related trials for Acute Stroke
Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
RecruitingPhase 3
Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
Acute Ischemic Stroke
RecruitingObservational study
FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
RecruitingPhase 3
Sevoflurane vs. Propofol for General Anesthesia in Patients With Acute Ischemic Stroke Treated With Endovascular Therapy
Acute Ischemic Stroke, Large Vessel Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Vandermeeren, MD, PhD principal investigator
University Hospital of Mont-Godinne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Acute Stroke and Dysphagia, run by University Hospital of Mont-Godinne at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VideoFluoroscopy (VFSS) (time frame: baseline, end of acute stroke phase, follow up (3, 6, 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.