StrokeNCT02422225
A Study of tDCS for Swallowing Difficulties in Stroke Patients
A study testing Eldith DC-STIMULATOR in people with Stroke, run by Pusan National University at 1 site in South Korea.
Trial summary
The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Eldith DC-STIMULATOR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis
- Subjects who have cortical or subcortical brain lesion
- Subjects who was diagnosed as stroke within 6 months
- Subjects ages from 18years to 80years old
- Subjects who have less than 5 points of DOSS score due to swallowing difficulty from CNS injury
- Subjects who is possible to receive swallowing function intervention 5 days a week
- Subjects who understand the purpose of the study and acquired the consent of the patient or caregiver
- Subjects who had no effect from brain stimulation or electrical stimulation therapy
Who cannot join
- Subjects who have pre-existing and active major neurological disease
- Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- Subjects who have brain lesion except cortex or subcortex area
- Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure
- Subjects who is estimated as not appropriate for the study by the investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 626-770
Yong Il Shin, MD.PhD, 82-55-360-2872 ext. 82-55-360-2872, rmshin01@gmail.com
Yong Il Shin, MD.PhD
About this study
Official title: Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)
The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.
Read the detailed description
120 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into three types; Anode-Anode dual stimulation group, Anode-Cathode dual stimulation group, Single stimulation group. 20-minutes session of the stimulation were applied 5 times a weeks for 2 weeks at pharyngeal motor cortex of affected or non-affected site. The patients were evaluated at baseline, immediately and 2 weeks after tDCS.
- Conditions
- Stroke
- Being tested
- Eldith DC-STIMULATOR, Sham Eldith DC-STIMULATOR
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eldith DC-STIMULATORDevice
Transcranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients
tDCS intervention]
- Intensity: 1.5mA for 20min Device: Neuroconn GmbH, Ilmenau, Germany
- Stimulation site <Experimental group>
- Anode-Anode dual stimulation group Anode: affected pharyngeal motor cortex / Cathode: affected supraorbit Anode: non-affected pharyngeal motor cortex / Cathode: non-affected supraorbit
- Anode-Cathode dual stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected pharyngeal motor cortex
- Single stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected supraorbit <Control group> Sham stimulation
Sham Eldith DC-STIMULATORDevice
| Study group | Role | What they receive |
|---|---|---|
| Eldith DC-STIMULATOR group | Experimental | Intervention:
20-minutes of transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (30 applications for each 3 groups: total 90 applications) Receives: Device: Eldith DC-STIMULATOR |
| sham-Eldith DC-STIMULATOR group | Sham comparator | Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications) Receives: Device: Sham Eldith DC-STIMULATOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)
Measured: up to 60 sec
Secondary outcomes (3)
American Speech-LanguageHearing Association(ASHA)-Norms
Change in swallowing function
Measured: up to 2 weeks after tDCS
Korean Version of Modified Barthel Index(K-MBI)
Change in activity of daily living
Measured: up to 2 weeks after tDCS
Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing
Change in swallowing function
Measured: 2 weeks after tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University
- Investigators
- Yong-Il Shin, Ph.D., Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422225
- Sponsor's protocol ID
- PNUYH-03-2015-004
- Status last verified
- Jul 2015
- First submitted
- 13 Apr 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lequerica AH, Kortte K. Therapeutic engagement: a proposed model of engagement in medical rehabilitation. Am J Phys Med Rehabil. 2010 May;89(5):415-22. doi: 10.1097/PHM.0b013e3181d8ceb2.
PubMed 20407308
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)
- ClinicalTrials.gov ID
- NCT02422225
- Acronym / sponsor ID
- PNUYH-03-2015-004
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Apr 2015 (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 primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.
Detailed description
120 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into three types; Anode-Anode dual stimulation group, Anode-Cathode dual stimulation group, Single stimulation group. 20-minutes session of the stimulation were applied 5 times a weeks for 2 weeks at pharyngeal motor cortex of affected or non-affected site. The patients were evaluated at baseline, immediately and 2 weeks after tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eldith DC-STIMULATOR group | Experimental | Device: Eldith DC-STIMULATORIntervention: 20-minutes of transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (30 applications for each 3 groups: total 90 applications) |
| sham-Eldith DC-STIMULATOR group | Sham comparator | Device: Sham Eldith DC-STIMULATORIntervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis
- Subjects who have cortical or subcortical brain lesion
- Subjects who was diagnosed as stroke within 6 months
- Subjects ages from 18years to 80years old
- Subjects who have less than 5 points of DOSS score due to swallowing difficulty from CNS injury
Key exclusion criteria (5 listed)
- Subjects who have pre-existing and active major neurological disease
- Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- Subjects who have brain lesion except cortex or subcortex area
- Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure
- Subjects who is estimated as not appropriate for the study by the investigators
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 |
|---|---|---|
| Eldith DC-STIMULATORTranscranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients tDCS intervention] * Intensity: 1.5mA for 20min Device: Neuroconn GmbH, Ilmenau, Germany * Stimulation site <Experimental group> * Anode-Anode dual stimulation group Anode: affected pharyngeal motor cortex / Cathode: affected supraorbit Anode: non-affected pharyngeal motor cortex / Cathode: non-affected supraorbit * Anode-Cathode dual stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected pharyngeal motor cortex * Single stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected supraorbit <Control group> Sham stimulation | Device | Eldith DC-STIMULATOR group |
| Sham Eldith DC-STIMULATOR | Device | sham-Eldith DC-STIMULATOR group |
Primary outcome
Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)
Time frame: up to 60 sec
3 secondary outcomes
American Speech-LanguageHearing Association(ASHA)-Norms
Time frame: up to 2 weeks after tDCS
Korean Version of Modified Barthel Index(K-MBI)
Time frame: up to 2 weeks after tDCS
Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing
Time frame: 2 weeks after tDCS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Background: PubMed 20407308Lequerica AH, Kortte K. Therapeutic engagement: a proposed model of engagement in medical rehabilitation. Am J Phys Med Rehabil. 2010 May;89(5):415-22. doi: 10.1097/PHM.0b013e3181d8ceb2.
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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.
Yong-Il Shin, Ph.D. principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eldith DC-STIMULATOR in people with Stroke, run by Pusan National University at 1 site in South Korea.
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 8 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: status not confirmed, as of the sponsor's last update on 22 Jul 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS) (time frame: up to 60 sec). 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 NCT02422225, which also lists 1 linked publication.
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 22 Jul 2015.