NCT06305949

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2024Jun 2026

First Submitted

Initial submission to the registry

February 26, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

February 26, 2024

Last Update Submit

April 7, 2026

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    Baseline, At 4 weeks from baseline

Secondary Outcomes (14)

  • Functional Oral Intake Scale (FOIS)

    Baseline, At 2, 4, and 8 weeks from baseline

  • Penetration-aspiration Scale (PAS)

    Baseline, At 2, 4, and 8 weeks from baseline

  • Videofluoroscopic Dysphagia Scale (VDS)

    Baseline, At 2, 4, and 8 weeks from baseline

  • Korean Mann Assessment of Swallowing Ability (K-MASA)

    Baseline, At 2, 4, and 8 weeks from baseline

  • Speech Mechanism Screening Test (SMST)

    Baseline, At 4, and 8 weeks from baseline

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Device: Sham transcranial Direct Current Stimulation

Interventions

Optimized transcranial Direct Current StimulationDEVICE

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

Also known as: NEUROPHET tES LAB, NEUROPHET innk01-DW
Optimized transcranial Direct Current Stimulation
Sham transcranial Direct Current StimulationDEVICE

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

Also known as: NEUROPHET tES LAB, NEUROPHET innk01-DW
Sham transcranial Direct Current Stimulation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, 14647, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41695623DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

TaeYeong Kim

CONTACT

827051678882ty.kim@neurophet.com

Seungeun Lee

CONTACT

selee@neurophet.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 12, 2024

Study Start

April 22, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

KR(1)