Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

NCT07766668 · tracked via the Priya Life Science China tracker

Sponsor

Zhejiang University

Phase

Not applicable

Started

2026-09-01

Last updated

2026-08-14

Condition(s) studied

Deglutition DisordersIschemic Stroke

Investigational drug(s) / intervention(s)

Active Transcranial Temporal Interference StimulationSham Transcranial Temporal Interference StimulationStandardized Task-Specific Swallowing Rehabilitation

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.

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.

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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 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

Primary outcome measure(s)

Change in Penetration-Aspiration Scale Score — Baseline and immediately after the 2-week intervention
The Penetration-Aspiration Scale (PAS) will be scored from videofluoroscopic swallowing study recordings using standardized boluses. Scores range from 1 to 8, with higher scores indicating greater airway invasion and worse swallowing safety. The worst PAS score across the prespecified bolus trials will be used. The primary outcome is the change in PAS score from baseline to immediately after the 2-week intervention.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766668 on ClinicalTrials.gov ↗ ← All trials in China