Optimized transcranial direct current stimulation for post-stroke dysphagia with small electrodes: a double-blind, randomized, feasibility study protocol.
TaeYeong Kim, Hae-Yeon Park, Sung-Hwa Ko...
https://pubmed.ncbi.nlm.nih.gov/41695623Actively Recruiting
Phase Not Applicable
Age: 19Years +
All Genders
ID06305949
A Multi-center, Randomized, Double-blind Pilot Study to Evaluate Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for Temporary Improvement of Swallowing in Post-Stroke Dysphagia
Led by NEUROPHET · Updated on 2026-04-09
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NEUROPHET
Lead Sponsor
B
Bucheon St. Mary's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether optimized transcranial direct current stimulation (tDCS) can temporarily improve swallowing function in patients who have difficulty swallowing due to stroke-related damage. This study compares the effects of optimized tDCS with sham stimulation in patients who have post-stroke dysphagia, aiming to understand if the targeted brain stimulation is more effective for improving swallowing. The trial is conducted as a multi-center, randomized, double-blind pilot study sponsored by NEUROPHET. Participants will receive either optimized tDCS or sham stimulation. The optimized stimulation is customized based on an individual's MRI to target the motor cortex area responsible for swallowing. Treatments are given once daily for 30 minutes, five days a week, over four weeks, totaling 20 sessions. The sham group will receive a similar setup without active stimulation to serve as a comparison. During the study, participants will undergo various assessments including swallowing function scales, speech and motor evaluations, and respiratory tests at baseline and at intervals up to eight weeks. Researchers will monitor swallowing ability, motor-evoked potentials, and other neurological and functional outcomes to measure improvement. Safety and tolerability will also be observed throughout the trial period, which lasts several weeks from the start of treatment to follow-up assessments.
CONDITIONS
Brief Title
Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Men and women aged over 19 years
- Patients with stroke confirmed by neuroimaging
- First-time stroke patients
- Patients in subacute or chronic stroke phase, at least 3 weeks after stroke onset
- Stroke patients with confirmed dysphagia by Videofluoroscopic Swallowing Study (VFSS)
You will not qualify if you...
- Patients with recurrent stroke, traumatic brain injury, spinal cord injury, or degenerative brain diseases like Parkinson's disease
- Patients with cognitive decline unable to follow study instructions
- Patients with delirium, confusion, or impaired consciousness
- Patients with uncontrolled medical or surgical conditions
- Patients ineligible for transcranial direct current stimulation due to scalp condition, metallic implants, pacemaker, or cochlear implant
- Patients who used similar stimulation devices in the past year or participated in related trials
- Patients with severe neurological disorders with major psychiatric conditions such as major depressive disorder or dementia
- Patients with uncontrolled epilepsy within the past 6 months
- Patients with contraindications for MRI or other neuroimaging tests
- Patients taking medications that affect brain function or requiring changes in such medications during the trial
- Patients who are pregnant, breastfeeding, or planning pregnancy during the trial
- Patients considered medically ineligible for participation beyond the criteria listed above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 4 weeks
Participants receive either optimized or sham transcranial Direct Current Stimulation for swallowing function improvement. The stimulation is applied for 30 minutes once a day.
20 daily visits (in-person)
Follow-up
Duration - 4 weeks
Participants are monitored for swallowing function and other health outcomes after completing stimulation treatment.
Visits at 2, 4, and 8 weeks from baseline
Trial Site Locations
Total: 1 location
1
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, South Korea, 14647
Actively Recruiting
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Research Team
T
TaeYeong Kim
S
Seungeun Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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