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Deglutition DisordersDENTIS-PSDNCT07766668

Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

A study testing Active Transcranial Temporal Interference Stimulation and Standardized Task-Specific Swallowing Rehabilitation in people with Deglutition Disorders and Ischemic Stroke, run by Zhejiang University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Deglutition Disorders, Ischemic Stroke
What is being tested?
Active Transcranial Temporal Interference Stimulation and Standardized Task-Specific Swallowing Rehabilitation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteChina
Study dates
1 Sep 2026to 1 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xing-Chen Zhou, Dr. contact

+86-18370133761

zhouxingchen0210@163.com

China1 site
  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Zuo-bing Chen, PhD, +86-13957116610, czb1971@zju.edu.cn

    Xing-Chen Zhou, PhD, +86-18370133761, zhouxingchen0210@163.com

Other trials in China

About this study

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

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
Read the detailed 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.

Being tested
Active Transcranial Temporal Interference Stimulation, Sham Transcranial Temporal Interference Stimulation, Standardized Task-Specific Swallowing Rehabilitation
Keywords
stroke, dysphagia, temporal interference stimulation, cerebellar dentate nucleus, swallowing rehabilitation, neuroplasticity, randomized controlled trial
Medical subject headings
Deglutition Disorders, Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Transcranial Temporal Interference StimulationDevice

    Also called Active tTIS, NervioX-1000

    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 StimulationDevice

    Also called Sham tTIS

    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 RehabilitationBehavioural

    Also called 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 groups in NCT07766668
Study groupRoleWhat they receive
Active tTIS GroupExperimentalMRI-modelled transcranial temporal interference stimulation targeting the dentate nucleus contralateral to the cerebral lesion. Two carrier frequencies of 2000 Hz and 2020 Hz are applied to generate a 20-Hz envelope. Stimulation is delivered for 30 minutes per session, 5 sessions per week for 2 weeks, followed by 30 minutes of standardized swallowing rehabilitation.
Receives: Device: Active Transcranial Temporal Interference Stimulation; Behavioral: Standardized Task-Specific Swallowing Rehabilitation
Sham tTIS GroupSham comparatorThe sham procedure uses the same individualized montage, cap, device display, session duration, and standardized swallowing rehabilitation as the active intervention. Current is ramped up and down briefly at the beginning and end of the 30-minute session, with no sustained stimulation between the ramps.
Receives: Device: Sham Transcranial Temporal Interference Stimulation; Behavioral: Standardized Task-Specific Swallowing Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and immediately after completion of the 2-week intervention

Secondary outcomes (8)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Change in Maximum Hyoid Displacement

    Maximum hyoid displacement will be measured in millimeters from videofluoroscopic swallowing recordings using anatomical calibration. Greater displacement generally indicates better hyolaryngeal excursion.

    Measured: Baseline and immediately after the 2-week intervention

  6. Change in Pharyngeal Transit Time

    Pharyngeal transit time will be measured in seconds from videofluoroscopic swallowing recordings. A shorter duration generally indicates more efficient pharyngeal bolus transport.

    Measured: Baseline and immediately after the 2-week intervention

  7. Incidence of Aspiration Pneumonia

    The number and proportion of participants who develop clinically adjudicated aspiration pneumonia will be recorded. Diagnosis will be based on prespecified clinical and radiological criteria by assessors unaware of treatment allocation.

    Measured: From randomization through the 12-week follow-up

  8. Incidence of Adverse Events

    The number and proportion of participants experiencing adverse events and serious adverse events will be recorded. Events of interest include headache, dizziness, nausea, fatigue, scalp discomfort, skin reactions, neurological deterioration, seizures, falls, hospitalization, and other medical events. Severity and relationship to the intervention will be assessed.

    Measured: During the 2-week intervention and through the 12-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion1 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: active transcranial temporal interference stimulation combined with standardized swallowing rehabilitation or sham stimulation combined with the same swallowing rehabilitation.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07766668
Sponsor's protocol ID
No. 2025YFC3608300
Acronym
DENTIS-PSD
Status last verified
Sep 2026
First submitted
9 Aug 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the primary publication will be available for sharing. Shared data may include clinical outcome measures, adverse-event data, and derived neurophysiological and imaging measures. A data dictionary will also be provided. Raw identifiable imaging files and information that could increase the risk of participant re-identification will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Active Transcranial Temporal Interference Stimulation and Standardized Task-Specific Swallowing Rehabilitation in people with Deglutition Disorders and Ischemic Stroke, run by Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xing-Chen Zhou, Dr. (+86-18370133761, zhouxingchen0210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-treatment Penetration-Aspiration Scale (PAS) score (time frame: Baseline and immediately after completion of the 2-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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