Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia (DENTIS-PSD)

Zhejiang University

Status: Not yet enrolling

Conditions: Ischemic Stroke; Deglutition Disorders

Treatments: Device: Active Transcranial Temporal Interference Stimulation; Device: Sham Transcranial Temporal Interference Stimulation; Behavioral: Standardized Task-Specific Swallowing Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07766668

No. 2025YFC3608300

Details and patient eligibility

About

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

Full description

Post-stroke dysphagia is associated with aspiration, pneumonia, malnutrition, prolonged hospitalization, functional dependence, and mortality. Although conventional swallowing rehabilitation can improve swallowing function, recovery is often incomplete. Transcranial temporal interference stimulation (tTIS) is an investigational, noninvasive neuromodulation technique that uses intersecting high-frequency electrical currents to generate a lower-frequency stimulation envelope within a selected deep-brain target.

This prospective, single-center, randomized, double-blind, sham-controlled trial will enroll 88 adults with dysphagia following a first unilateral supratentorial ischemic stroke. Participants will be randomly assigned in a 1:1 ratio to receive active or sham tTIS. Both groups will receive identical task-specific swallowing rehabilitation. The stimulation target will be the cerebellar dentate nucleus contralateral to the cerebral lesion. Individual structural magnetic resonance imaging and finite-element electric-field modelling will be used to optimize electrode placement and the current ratio for each participant.

The active intervention will use two carrier frequencies of 2000 and 2020 Hz to generate a 20-Hz envelope. Each stimulation session will last 30 minutes and will be followed by standardized swallowing rehabilitation. Participants will receive 10 weekday sessions over 2 consecutive weeks. The sham group will undergo the same procedures and treatment schedule without sustained active stimulation.

Clinical assessments will be conducted at baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up. Videofluoroscopic swallowing studies will be used to evaluate swallowing safety and efficiency. Neurophysiological testing and resting-state functional magnetic resonance imaging will be used to explore whether treatment-related swallowing improvement is associated with changes in corticobulbar excitability and functional connectivity within the dentato-thalamo-cortical swallowing network.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

Active tTIS Group

Experimental group

Description:

Participants will receive individualized active transcranial temporal interference stimulation targeting the cerebellar dentate nucleus contralateral to the cerebral lesion, followed by standardized task-specific swallowing rehabilitation. Treatment will be administered for 30 minutes per session, 5 sessions per week for 2 consecutive weeks, for a total of 10 sessions.

Treatment:

Behavioral: Standardized Task-Specific Swallowing Rehabilitation

Device: Active Transcranial Temporal Interference Stimulation

Sham tTIS Group

Sham Comparator group

Description:

Participants will receive sham transcranial temporal interference stimulation followed by the same standardized task-specific swallowing rehabilitation. The sham procedure will use the same device, electrode montage, session duration, and ramp sensations as active stimulation but will not deliver sustained active stimulation. Treatment will be administered 5 sessions per week for 2 consecutive weeks, for a total of 10 sessions.

Treatment:

Behavioral: Standardized Task-Specific Swallowing Rehabilitation

Device: Sham Transcranial Temporal Interference Stimulation