An interventional study of Active Transcranial Temporal Interference Stimulation and Sham Transcranial Temporal Interference Stimulation in Deglutition Disorders and Ischemic Stroke, sponsored by Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Zhejiang University · Not applicable, Interventional, and Treatment
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:
Researchers will compare active stimulation with sham stimulation, which uses the same equipment but does not deliver sustained therapeutic stimulation.
Participants will:
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 112 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Zhejiang University is the lead sponsor of 356 studies on the registry; 166 are open to participants now.
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The criteria were revised on the registry on Oct 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MRI-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.
Device: Active Transcranial Temporal Interference Stimulation · Behavioral: Standardized Task-Specific Swallowing Rehabilitation
The 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.
Device: Sham Transcranial Temporal Interference Stimulation · Behavioral: Standardized Task-Specific Swallowing Rehabilitation
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.
Also known as: Active tTIS, NervioX-1000
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.
Also known as: Sham tTIS
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.
Also known as: Swallowing Rehabilitation
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
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
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.
Time frame: Baseline and immediately after the 2-week intervention
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.
Time frame: Baseline and immediately after the 2-week intervention
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.
Time frame: From randomization through the 12-week follow-up
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.
Time frame: During the 2-week intervention and through the 12-week follow-up
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
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will become available 12 months after publication of the primary trial results and will remain available for 5 years.
Access criteria: Access will be considered for qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the principal investigator and the sponsoring institution. Approved applicants will be required to sign a data-use agreement and use the data only for the approved research purpose. Requests should be directed to the corresponding author.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 39 months is above that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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