StrokeNCT01970384
Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients
A study testing Transcranial direct current stimulation in people with Stroke and Dysphagia, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate whether transcranial direct current stimulation of the cerebral swallow motor cortex in addition to standard care can enhance recovery of swallow function in acute dysphagic stroke patients compared to sham treatment plus standard care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Dec 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dysphagia due to acute stroke
Who cannot join
- preexisting dysphagia
- comorbidities that can possibly cause dysphagia
- psychiatric comorbidities
- pacemaker or other implanted electronic devices
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether transcranial direct current stimulation of the cerebral swallow motor cortex in addition to standard care can enhance recovery of swallow function in acute dysphagic stroke patients compared to sham treatment plus standard care.
- Being tested
- Transcranial direct current stimulation, Sham stimulation
- Keywords
- transcranial direct current stimulation, stroke-related dysphagia, cortical plasticity
- 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 stimulationDevice
Also called tDCS
20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere.
Sham stimulationDevice
Also called sham tDCS
20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Experimental | 20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere. Receives: Device: Transcranial direct current stimulation |
| Sham stimulation | Sham comparator | 20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score
Measured: Within three days after the last stimulation session
Secondary outcomes (3)
Diet at discharge
Measured: by the time of discharge, an expected average of 2 weeks after the last stimulation session
Dysphagia Severity Rating Score
Measured: within three days after the last stimulation session
Endoscopically assessed swallow function
Improvement of salient endoscopic findings
Measured: within three days after the last stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Dziewas, PhD, Principal investigator, Department of Neurology, University of Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970384
- Sponsor's protocol ID
- 2010-140
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2013
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suntrup S, Teismann I, Wollbrink A, Winkels M, Warnecke T, Floel A, Pantev C, Dziewas R. Magnetoencephalographic evidence for the modulation of cortical swallowing processing by transcranial direct current stimulation. Neuroimage. 2013 Dec;83:346-54. doi: 10.1016/j.neuroimage.2013.06.055. Epub 2013 Jun 23.
PubMed 23800793Dziewas R, Warnecke T, Olenberg S, Teismann I, Zimmermann J, Kramer C, Ritter M, Ringelstein EB, Schabitz WR. Towards a basic endoscopic assessment of swallowing in acute stroke - development and evaluation of a simple dysphagia score. Cerebrovasc Dis. 2008;26(1):41-7. doi: 10.1159/000135652. Epub 2008 May 30.
PubMed 18511871
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT01970384
- Acronym / sponsor ID
- 2010-140
- Keywords
- transcranial direct current stimulation, stroke-related dysphagia, cortical plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Oct 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.
The purpose of this study is to evaluate whether transcranial direct current stimulation of the cerebral swallow motor cortex in addition to standard care can enhance recovery of swallow function in acute dysphagic stroke patients compared to sham treatment plus standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Device: Transcranial direct current stimulation20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere. |
| Sham stimulation | Sham comparator | Device: Sham stimulation20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dysphagia due to acute stroke
Key exclusion criteria (5 listed)
- preexisting dysphagia
- comorbidities that can possibly cause dysphagia
- psychiatric comorbidities
- pacemaker or other implanted electronic devices
- inability to give informed consent
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 stimulationAlso: tDCS20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere. | Device | Transcranial direct current stimulation |
| Sham stimulationAlso: sham tDCS20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere. | Device | Sham stimulation |
Primary outcome
FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score
Time frame: Within three days after the last stimulation session
3 secondary outcomes
Diet at discharge
Time frame: by the time of discharge, an expected average of 2 weeks after the last stimulation session
Dysphagia Severity Rating Score
Time frame: within three days after the last stimulation session
Endoscopically assessed swallow function
Time frame: within three days after the last stimulation session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 23800793Suntrup S, Teismann I, Wollbrink A, Winkels M, Warnecke T, Floel A, Pantev C, Dziewas R. Magnetoencephalographic evidence for the modulation of cortical swallowing processing by transcranial direct current stimulation. Neuroimage. 2013 Dec;83:346-54. doi: 10.1016/j.neuroimage.2013.06.055. Epub 2013 Jun 23.
- Background: PubMed 18511871Dziewas R, Warnecke T, Olenberg S, Teismann I, Zimmermann J, Kramer C, Ritter M, Ringelstein EB, Schabitz WR. Towards a basic endoscopic assessment of swallowing in acute stroke - development and evaluation of a simple dysphagia score. Cerebrovasc Dis. 2008;26(1):41-7. doi: 10.1159/000135652. Epub 2008 May 30.
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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.
Rainer Dziewas, PhD principal investigator
Department of Neurology, University of Muenster
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 in people with Stroke and Dysphagia, run by University Hospital Muenster at 1 site in Germany.
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 5 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: finished, as of the sponsor's last update on 14 Oct 2015. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FEDSS (Fiberoptic Endoscopic Dysphagia Severity Scale) Score (time frame: Within three days after the last stimulation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01970384, which also lists 2 linked publications.
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 14 Oct 2015; AzTrials last refreshed its copy on 4 Nov 2026.