Deglutition DisordersNCT06305949
Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia
A study testing Optimized transcranial Direct Current Stimulation in people with Deglutition Disorders, run by NEUROPHET at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- Optimized transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women >19 years old
- patients with stroke confirmed by neuroimaging
- first-time stroke patients
- patients in subacute or chronic phases of stroke with 3 weeks or more after onset
- stroke patients with confirmed dysphagia through Videofluoroscopic Swallowing Study (VFSS).
Who cannot join
- patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as Parkinson's disease, etc.
- patients with deteriorated cognitive function unable to perform the clinical trial as instructed
- patients with evidence of delirium, confusion, or other impairment of consciousness
- patients with uncontrolled medical disease or surgical conditions
- patients ineligible for Transcranial direct current stimulation (due to scalp condition, metallic material at the electrode attachment area, presence of a pacemaker or cochlear implant)
- patients with previous experience within the last year using a stimulation device similar to the one use in this clinical trial or who have participated in related clinical trials
Show all 12Show fewer
- patients with severe neurologic disorder with concomitant major psychiatric disorder such as major depressive disorder and dementia
- patients with history of uncontrolled epilepsy within 6 months
- patients with medical contraindications for neuroimaging test, such as MRI;
- patients who are taken contraindicated medications or require medication changes during the trial period that could influence cognitive/motor function changes via brain activation changes
- patients who are pregnant, breastfeeding, or planning pregnancy during the trial period
- patients considered medically ineligible for participation in the present trial beyond the criteria listened above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Seungeun Lee contact
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, 14647
About this study
Official title: A Multi-center, Randomized, Double-blind, Pilot Study to Evaluate the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Transitory Improvement of Swallowing Function in Patients With Post-stroke Dysphagia
The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.
- Conditions
- Deglutition Disorders
- Being tested
- Optimized transcranial Direct Current Stimulation, Sham transcranial Direct Current Stimulation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized transcranial Direct Current StimulationDevice
Also called NEUROPHET tES LAB, NEUROPHET innk01-DW
transcranial Direct Current Stimulation 2mA for 30 min; The anode electrode will be located over the contralesional representation of the motor cortex swallowing area, while the cathode electrode will be positioned on the ipsilesional side
Sham transcranial Direct Current StimulationDevice
Also called NEUROPHET tES LAB, NEUROPHET innk01-DW
transcranial Direct Current sham Stimulation for 30 min; The anode electrode will be located over the contralesional representation of the motor cortex swallowing area, while the cathode electrode will be positioned on the ipsilesional side
| Study group | Role | What they receive |
|---|---|---|
| Optimized transcranial Direct Current Stimulation | Experimental | Patients receive optimized stimulation obtained from an individualized T1 MRI-based simulation of transcranial direct current stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions. Receives: Device: Optimized transcranial Direct Current Stimulation |
| Sham transcranial Direct Current Stimulation | Sham comparator | Patients receive sham stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions. Receives: Device: Sham transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Oral Intake Scale (FOIS)
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet)
Measured: Baseline, At 4 weeks from baseline
Penetration-aspiration Scale (PAS)
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject)
Measured: Baseline, At 4 weeks from baseline
Secondary outcomes (14)
Functional Oral Intake Scale (FOIS)
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet)
Measured: Baseline, At 2, 4, and 8 weeks from baseline
Penetration-aspiration Scale (PAS)
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject)
Measured: Baseline, At 2, 4, and 8 weeks from baseline
Videofluoroscopic Dysphagia Scale (VDS)
The scale contains 14 categories that represent both oral functions (lip, closure, mastication , bolus formation, premature bolus loss, apraxia and oral transit time) and pharyngeal functions (pharyngeal triggering, laryngeal elevation, epiglottic closure, pharyngeal transit time, pharyngeal coating, vallecular and pyriform sinus residues, and tracheal aspiration), with a sum of 100 points.
Measured: Baseline, At 2, 4, and 8 weeks from baseline
Korean Mann Assessment of Swallowing Ability (K-MASA)
K-MASA assesses 24 skills related to sensory and oral motor elements of swallowing. Performance for each skill is measured using a 5- or 10-points rating scale and tallied to create a total numeric score out of 200 possible points, which are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167) and severe (≤138)
Measured: Baseline, At 2, 4, and 8 weeks from baseline
Speech Mechanism Screening Test (SMST)
The test consists of 13 questions to evaluate the structure of the articulatory system, including the face, lips, tongue, jaw, teeth, oral cavity, soft palate, pharynx, and breathing; 17 questions to evaluate the function of the articulatory system; 3 questions to auditorily evaluate the structure and function of the vocal system; and 14 questions to evaluate the regularity and articulation accuracy of the mutual movement of the articulatory system during articulatory alternation.
Measured: Baseline, At 4, and 8 weeks from baseline
Urimal Test of Articulation and Phonology (U-TAP)
U-TAP is a test designed for native speakers of the Korean language. It is aimed to evaluate the pronunciation produced in words and sentences by patients with speech sound disorders who have problems with consonant or vowel sounds. It is recorded by phonological word and syllable position and calculates consonant accuracy and word-level phonological indices at the word and sentence levels to compare with normal articulation development
Measured: Baseline, At 4, and 8 weeks from baseline
modified Rankin Scale (mRS)
mRS is composed of a 6-point assessment that includes reference to both limitations in activity and changes in lifestyle. The mRS possible scores vary from 0 (no symptoms) to 6 (dead) points
Measured: Baseline, At 2, 4, and 8 weeks from baseline
Gugging Swallowing Screen
The assessment is composed of two parts, the preliminary assessment (indirect swallowing test) and the direct swallowing test, which consist of 4 items with 3 subtests (semisolid, liquid and solid). The test is based on a pointing system where higher numbers denote better performance, with a maximum of 5 points that can be reached in each subtest.
Measured: Baseline, At 2, 4, and 8 weeks from baseline
Eating Assessment Tool-10 (EAT-10)
The EAT-10 is a tool to assess self-perceived symptoms of oropharyngeal dysphagia and monitor changes in response to a treatment. It consists of ten items to be rated on a 5-point response scale (0-4), with "0" = No problem and "4" = Severe problem, the maximum score possible is 40.
Measured: Baseline, At 2, 4, and 8 weeks from baseline
Iowa Oral Performance Instrument (IOPI)
IOPI is a standardized portable device that is used to quantify tongue and lips isometric strength and endurance.
Measured: Baseline, At 4, and 8 weeks from baseline
Motor-Evoked Potential (MEP)
The cortical excitability of the area corresponding to the swallowing movement will be assessed by changes in the amplitude and latency of the MEPs by using transcranial magnetic stimulation (TMS).
Measured: Baseline, At 2 and 4 weeks from baseline
Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale)
GRBAS scale is used by researchers and clinicians for rating voice quality using a 4-point Likert scale with the following judgments: 0 = normal, 1 = mild impairment, 2 = moderate impairment, and 3 = severe impairment.
Measured: Baseline, At 4, and 8 weeks from baseline
Respiratory muscle strength
Respiratory muscle strength will be assessed by maximal inspiratory and expiratory pressure
Measured: Baseline, At 4, and 8 weeks from baseline
Peak cough flow
Peak cough flow measures the maximum expiratory flow during the compressive phase of a cough just after sudden opening of the glottis
Measured: Baseline, At 4, and 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start22 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (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 Deglutition DisordersStudies 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
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEUROPHET
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bucheon St. Mary's Hospital, Saint Vincent's Hospital, Korea, National Traffic Injury Rehabilitation Hospital, Pusan National University Yangsan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305949
- Sponsor's protocol ID
- XC23DDDS0098
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim T, Park HY, Ko SH, Yoo YJ, Jang H, Oh HM, Yoon MJ, Park GY, Kim D, Kim TW, Im S. Optimized transcranial direct current stimulation for post-stroke dysphagia with small electrodes: a double-blind, randomized, feasibility study protocol. Front Neurol. 2026 Jan 29;17:1660298. doi: 10.3389/fneur.2026.1660298. eCollection 2026.
PubMed 41695623
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Pilot Study to Evaluate the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Transitory Improvement of Swallowing Function in Patients With Post-stroke Dysphagia
- ClinicalTrials.gov ID
- NCT06305949
- Acronym / sponsor ID
- XC23DDDS0098
- Conditions
- Deglutition Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NEUROPHETIndustry (pharma, biotech, devices)
- Collaborators
- Bucheon St. Mary's Hospital, Saint Vincent's Hospital, Korea, National Traffic Injury Rehabilitation Hospital, Pusan National University Yangsan Hospital
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- 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 goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized transcranial Direct Current Stimulation | Experimental | Device: Optimized transcranial Direct Current StimulationPatients receive optimized stimulation obtained from an individualized T1 MRI-based simulation of transcranial direct current stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions. |
| Sham transcranial Direct Current Stimulation | Sham comparator | Device: Sham transcranial Direct Current StimulationPatients receive sham stimulation for 30 minutes, once a day for 4 weeks, for a total of 20 sessions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- men and women >19 years old
- patients with stroke confirmed by neuroimaging
- first-time stroke patients
- patients in subacute or chronic phases of stroke with 3 weeks or more after onset
- stroke patients with confirmed dysphagia through Videofluoroscopic Swallowing Study (VFSS).
Key exclusion criteria (12 listed)
- patients with recurrent stoke, traumatic brain injury, spine cord injury, and degenerative brain disease, such as Parkinson's disease, etc.
- patients with deteriorated cognitive function unable to perform the clinical trial as instructed
- patients with evidence of delirium, confusion, or other impairment of consciousness
- patients with uncontrolled medical disease or surgical conditions
- patients ineligible for Transcranial direct current stimulation (due to scalp condition, metallic material at the electrode attachment area, presence of a pacemaker or cochlear implant)
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 |
|---|---|---|
| Optimized transcranial Direct Current StimulationAlso: NEUROPHET tES LAB, NEUROPHET innk01-DWtranscranial Direct Current Stimulation 2mA for 30 min; The anode electrode will be located over the contralesional representation of the motor cortex swallowing area, while the cathode electrode will be positioned on the ipsilesional side | Device | Optimized transcranial Direct Current Stimulation |
| Sham transcranial Direct Current StimulationAlso: NEUROPHET tES LAB, NEUROPHET innk01-DWtranscranial Direct Current sham Stimulation for 30 min; The anode electrode will be located over the contralesional representation of the motor cortex swallowing area, while the cathode electrode will be positioned on the ipsilesional side | Device | Sham transcranial Direct Current Stimulation |
Primary outcome
Functional Oral Intake Scale (FOIS)
Time frame: Baseline, At 4 weeks from baseline
FOIS is a scale used for purposes to assess changes in functional oral intake of food and liquids in patients with dysphagia. FOIS is sensitive to changes in oral intake of food and liquid over time in stroke patients. The scale ranges from level 1 (nothing by mouth) to level 7 (a full unrestricted oral diet)
Penetration-aspiration Scale (PAS)
Time frame: Baseline, At 4 weeks from baseline
PAS is a standard scale to assess deglutition in clinical practice and research. It is composed of an 8-point scale used to characterize both the location of airway invasion events and patient's response during video fluoroscopic swallowing studies. The scale design to capture three constructs: depth of airway invasion, material remaining after swallow, and patient's response to aspiration. The scale ranges from score 1 (Material does not enter the airway) to score 8 (Material enters the airway, passes below the level of the vocal folds, and no effort is made to eject)
14 secondary outcomes
Functional Oral Intake Scale (FOIS)
Time frame: Baseline, At 2, 4, and 8 weeks from baseline
Penetration-aspiration Scale (PAS)
Time frame: Baseline, At 2, 4, and 8 weeks from baseline
Videofluoroscopic Dysphagia Scale (VDS)
Time frame: Baseline, At 2, 4, and 8 weeks from baseline
Korean Mann Assessment of Swallowing Ability (K-MASA)
Time frame: Baseline, At 2, 4, and 8 weeks from baseline
Speech Mechanism Screening Test (SMST)
Time frame: Baseline, At 4, and 8 weeks from baseline
Urimal Test of Articulation and Phonology (U-TAP)
Time frame: Baseline, At 4, and 8 weeks from baseline
modified Rankin Scale (mRS)
Time frame: Baseline, At 2, 4, and 8 weeks from baseline
Gugging Swallowing Screen
Time frame: Baseline, At 2, 4, and 8 weeks from baseline
Eating Assessment Tool-10 (EAT-10)
Time frame: Baseline, At 2, 4, and 8 weeks from baseline
Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline, At 4, and 8 weeks from baseline
Motor-Evoked Potential (MEP)
Time frame: Baseline, At 2 and 4 weeks from baseline
Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale)
Time frame: Baseline, At 4, and 8 weeks from baseline
Respiratory muscle strength
Time frame: Baseline, At 4, and 8 weeks from baseline
Peak cough flow
Time frame: Baseline, At 4, and 8 weeks from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 41695623Kim T, Park HY, Ko SH, Yoo YJ, Jang H, Oh HM, Yoon MJ, Park GY, Kim D, Kim TW, Im S. Optimized transcranial direct current stimulation for post-stroke dysphagia with small electrodes: a double-blind, randomized, feasibility study protocol. Front Neurol. 2026 Jan 29;17:1660298. doi: 10.3389/fneur.2026.1660298. eCollection 2026.
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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.
Seungeun Lee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized transcranial Direct Current Stimulation in people with Deglutition Disorders, run by NEUROPHET 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TaeYeong Kim (827051678882, ty.kim@neurophet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Oral Intake Scale (FOIS) (time frame: Baseline, At 4 weeks from baseline). 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?
On the ClinicalTrials.gov record for NCT06305949, 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 9 Apr 2026.