Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

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

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.

Sponsors & Collaborators

• Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-12-30

Completion

2030-03-01

Countries

• China

Study Locations