Brain stimulation with swallowing rehabilitation for swallowing problems after ischemic stroke
Tests temporal interference brain stimulation with swallowing rehabilitation in adults after ischemic stroke.
Plain-language title generated from the registry record
Registry title: Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia
Key facts
- Where
- Hangzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07766668, who can take part
Where in China
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT07766668
- Record updated
- 2 October 2026
- Original description
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:Read full original descriptionShow less
Individualized Transcranial Temporal Interference Stimulation Targeting the Dentato-Thalamo-Cortical Pathway for Post-Stroke Dysphagia: A Randomized, Double-Blind, Sham-Controlled Trial
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
Inclusion: 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 (PAS) score of 3 to 8 during prespecified standardized bolus trials; For participants with a PAS score of 8, clinical stability and the ability to undergo videofluoroscopic swallowing assessment safely, as determined by the study clinician; 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: 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; Intracranial metallic material, implanted electronic device, cochlear implant, or another contraindication to transcranial temporal interference stimulation, magnetic resonance imaging, or transcranial magnetic stimulation; History of epilepsy, seizure after the index stroke, unexplained loss of consciousness, or current use of medication considered to confer an unacceptable seizure risk; Severe cognitive, behavioral, or language impairment that prevents participation despite supported communication; Major scalp disease at the planned electrode sites; Any other condition considered unsafe or unsuitable by the investigator; Tracheostomy, current mechanical ventilation, uncontrolled pneumonia, severe hypoxemia, or hemodynamic instability; Pregnancy or breastfeeding; Participation in another interventional clinical trial.