Not Yet RecruitingNot Applicable

Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

China88 participantsStarted 2026-09-01

Plain-language summary

The goal of this clinical trial is to learn whether individualized transcranial temporal interference stimulation can improve swallowing in adults with swallowing difficulties after an ischemic stroke. It will also evaluate the safety and tolerability of this stimulation. The main questions it aims to answer are: * Does active temporal interference stimulation combined with swallowing rehabilitation improve swallowing safety more than sham stimulation combined with the same rehabilitation? * What side effects or medical problems occur during and after the stimulation? Researchers will compare active stimulation with sham stimulation, which uses the same equipment but does not deliver sustained therapeutic stimulation. Participants will: * Receive active or sham stimulation for 30 minutes per session, 5 days per week for 2 weeks * Receive the same task-specific swallowing rehabilitation after each stimulation session * Undergo swallowing assessments, brain imaging, and neurophysiological testing * Attend follow-up assessments 4 and 12 weeks after treatment

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 80 years * First-ever unilateral supratentorial ischemic stroke confirmed by computed tomography or magnetic resonance imaging * Stroke onset 14 to 90 days before randomization * Oropharyngeal dysphagia confirmed by videofluoroscopic swallowing study, with a worst Penetration-Aspiration Scale score of 3 to 7 during prespecified standardized bolus trials * Medically stable and able to remain seated during stimulation and swallowing rehabilitation * Able to follow one-step commands, directly or with supported communication * Written informed consent provided by the participant or a legally authorized representative Exclusion Criteria: * Brainstem or primary cerebellar stroke, bilateral cerebral infarction, previous symptomatic stroke, intracranial hemorrhage, or progressive neurological disease * Pre-stroke dysphagia, structural oropharyngeal disease, previous treatment for head and neck cancer, or another condition that independently explains dysphagia * Tracheostomy, current mechanical ventilation, uncontrolled pneumonia, severe hypoxemia, or hemodynamic instability * History of epilepsy, seizure after the index stroke, unexplained loss of consciousness, or current use of medication considered to confer an unacceptable seizure risk * Intracranial metallic material, implanted electronic device, cochlear implant, or another contraindication to transcranial temporal interference stimulation, magnetic resonance imaging, or transcranial magnetic …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Penetration-Aspiration Scale Score

Timeframe: Baseline and immediately after the 2-week intervention

Trial details

NCT IDNCT07766668

SponsorZhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-30

Contact for this trial

Xing-Chen Zhou, Dr.

+86-18370133761 zhouxingchen0210@163.com

View on ClinicalTrials.gov More Deglutition Disorders trials