Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia

NCT06305949 · tracked via the Priya Life Science South Korea tracker

Sponsor

NEUROPHET

Phase

Not applicable

Started

2024-04-22

Last updated

2026-04-09

Condition(s) studied

Deglutition Disorders

Investigational drug(s) / intervention(s)

Optimized transcranial Direct Current StimulationSham transcranial Direct Current Stimulation

Optimized transcranial Direct Current Stimulation: 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 Stimulation: 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 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Primary outcome measure(s)

Functional Oral Intake Scale (FOIS) — 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) — 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)

Trial sites (1)

Facility	City	Region	Status
The Catholic University of Korea, Bucheon St. Mary's Hospital	Bucheon-si	South Korea	Recruiting

More NEUROPHET trials in South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06305949 on ClinicalTrials.gov ↗ ← All trials in South Korea