Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang University
About this 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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Active Transcranial Temporal Interference Stimulation
- Sham Transcranial Temporal Interference Stimulation
- Standardized Task-Specific Swallowing Rehabilitation
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
Source ClinicalTrials.gov