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Not Yet Recruiting NCT07766668

Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

Conditions: Deglutition Disorders, Ischemic Stroke

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 112
Sponsor: Zhejiang University

Location: The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

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

Eligibility Criteria

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 (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 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 stimulation * Severe cognitive, behavioral, or language impairment that prevents participation despite supported communication * Pregnancy or breastfeeding * Major scalp disease at the planned electrode sites * Participation in another interventional clinical trial * Any other condition considered unsafe or unsuitable by the investigator

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07766668). StuddyBuddy aggregates publicly available trial information.