Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

ConditionsDeglutition Disorders Ischemic Stroke

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

This trial does not accept healthy volunteers

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 (PAS) score of 3 to 8 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

Design model

Parallel

Treatments tested in this trial

Active Transcranial Temporal Interference Stimulation
Device
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
Device
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
Behavioral
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.

Treatment groups

112 Participants

are divided into 2 treatment groups

Group A: Active tTIS GroupExperimental treatment 2 interventions

Group B: Sham tTIS GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

Post-treatment Penetration-Aspiration Scale (PAS) score

PAS will be assessed using a standardized videofluoroscopic swallowing study. The prespecified scoring rule and bolus protocol will be applied consistently at baseline and post-treatment. PAS ranges from 1 to 8, with higher scores indicating more severe airway invasion. The primary between-group comparison will assess the post-treatment ordinal PAS distribution adjusted for baseline PAS.

Time frame

Baseline and immediately after completion of the 2-week intervention

Secondary outcomes

Change in Dynamic Imaging Grade of Swallowing Toxicity

The Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) will be derived from videofluoroscopic swallowing studies. The overall grade ranges from 0 to 4, with higher grades indicating more severe swallowing impairment. Safety and efficiency grades will also be recorded.

Time frame

Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up

Change in Functional Oral Intake Scale Score

The Functional Oral Intake Scale (FOIS) evaluates the level of oral food and liquid intake. Scores range from 1 to 7, with higher scores indicating greater oral intake and less dependence on tube feeding or dietary modification.

Time frame

Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up

Change in Standardized Swallowing Assessment Score

The Standardized Swallowing Assessment will be used to evaluate clinical signs of swallowing impairment. Higher scores indicate more severe dysphagia.

Time frame

Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up

Change in Swallowing Quality of Life Questionnaire Score

The Swallowing Quality of Life Questionnaire (SWAL-QOL) will assess the participant-reported effects of dysphagia on daily life. Scores are transformed to a 0-to-100 scale, with higher scores indicating better swallowing-related quality of life.

Time frame

Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up

Other outcomes

Change in Pharyngeal Motor-Evoked Potential Amplitude

Pharyngeal motor-evoked potential amplitude will be measured using single-pulse transcranial magnetic stimulation and electromyography. The outcome will be used to explore changes in corticobulbar excitability associated with treatment.

Time frame

Baseline and immediately after the 2-week intervention

Change in Dentato-Thalamo-Cortical Functional Connectivity

Resting-state functional magnetic resonance imaging will be used to measure functional connectivity between the targeted cerebellar dentate nucleus, thalamus, and cortical swallowing regions. Connectivity values will be compared between baseline and post-treatment assessments.

Time frame

Baseline and immediately after the 2-week intervention

Sponsors and contacts

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Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Source ClinicalTrials.gov

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