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NCT07766668

Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

Sponsor: Zhejiang University

View on ClinicalTrials.gov

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

Official title: Individualized Transcranial Temporal Interference Stimulation Targeting the Dentato-Thalamo-Cortical Pathway for Post-Stroke Dysphagia: A Randomized, Double-Blind, Sham-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-09-01

Completion Date

2030-03-01

Last Updated

2026-10-02

Healthy Volunteers

Conditions

Deglutition Disorders Ischemic Stroke

Interventions

DEVICE

Active Transcranial Temporal Interference Stimulation

Individualized active stimulation will be delivered using the NervioX-1000 temporal interference stimulation system. The cerebellar dentate nucleus contralateral to the cerebral lesion will be targeted using an electrode montage and current ratio optimized from individual structural magnetic resonance imaging and finite-element electric-field modelling. Carrier frequencies of 2000 and 2020 Hz will generate a 20-Hz envelope. The maximum peak-to-baseline current will be 2.0 mA. Each session will last 30 minutes, including 30-second ramp-up and ramp-down periods. Treatment will be delivered on 10 weekdays over 2 consecutive weeks.

DEVICE

Sham Transcranial Temporal Interference Stimulation

Sham stimulation will be delivered using the same device, individualized electrode montage, positioning procedures, and session schedule as active stimulation. The device will reproduce the initial ramp-up and brief stimulation sensations and will then ramp down without delivering sustained active stimulation. A brief terminal ramp will reproduce end-of-session sensations. Each sham session will last 30 minutes, and 10 sessions will be administered over 2 consecutive weeks.

BEHAVIORAL

Standardized Task-Specific Swallowing Rehabilitation

Both groups will receive 30 minutes of standardized task-specific swallowing rehabilitation immediately after each active or sham stimulation session. Treatment will be selected according to each participant's swallowing impairment and may include effortful swallowing, the Mendelsohn maneuver, tongue-resistance exercise, chin-tuck-against-resistance exercise, sensory stimulation, and task-specific swallowing practice using clinically appropriate bolus volumes and consistencies.

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

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China