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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Functional Oral Intake Scale (FOIS) [Срок оценки: Baseline, At 4 weeks from baseline]
• Penetration-aspiration Scale (PAS) [Срок оценки: Baseline, At 4 weeks from baseline]

Вторичные конечные точки (12)

• Functional Oral Intake Scale (FOIS) [Срок оценки: Baseline, At 2, 4, and 8 weeks from baseline]
• Penetration-aspiration Scale (PAS) [Срок оценки: Baseline, At 2, 4, and 8 weeks from baseline]
• Videofluoroscopic Dysphagia Scale (VDS) [Срок оценки: Baseline, At 2, 4, and 8 weeks from baseline]
• Korean Mann Assessment of Swallowing Ability (K-MASA) [Срок оценки: Baseline, At 2, 4, and 8 weeks from baseline]
• Speech Mechanism Screening Test (SMST) [Срок оценки: Baseline, At 4, and 8 weeks from baseline]
• Urimal Test of Articulation and Phonology (U-TAP) [Срок оценки: Baseline, At 4, and 8 weeks from baseline]
• modified Rankin Scale (mRS) [Срок оценки: Baseline, At 2, 4, and 8 weeks from baseline]
• Gugging Swallowing Screen [Срок оценки: Baseline, At 2, 4, and 8 weeks from baseline]
• Eating Assessment Tool-10 (EAT-10) [Срок оценки: Baseline, At 2, 4, and 8 weeks from baseline]
• Iowa Oral Performance Instrument (IOPI) [Срок оценки: Baseline, At 4, and 8 weeks from baseline]
• Motor-Evoked Potential (MEP) [Срок оценки: Baseline, At 2 and 4 weeks from baseline]
• Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale) [Срок оценки: Baseline, At 4, and 8 weeks from baseline]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• The Catholic University of Korea, Bucheon St. Mary's Hospital — Bucheon-si

Публикации

• 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 41695623

Идентификаторы

NCT: NCT06305949 · XC23DDDS0098

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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