Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia
DENTIS-PSD
Individualized Transcranial Temporal Interference Stimulation Targeting the Dentato-Thalamo-Cortical Pathway for Post-Stroke Dysphagia: A Randomized, Double-Blind, Sham-Controlled Trial
1 other identifier
interventional
88
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2026
CompletedFirst Posted
Study publicly available on registry
August 14, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2029
Study Completion
Last participant's last visit for all outcomes
March 1, 2030
August 14, 2026
August 1, 2026
3.3 years
August 9, 2026
August 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Penetration-Aspiration Scale Score
The Penetration-Aspiration Scale (PAS) will be scored from videofluoroscopic swallowing study recordings using standardized boluses. Scores range from 1 to 8, with higher scores indicating greater airway invasion and worse swallowing safety. The worst PAS score across the prespecified bolus trials will be used. The primary outcome is the change in PAS score from baseline to immediately after the 2-week intervention.
Baseline and immediately after the 2-week intervention
Secondary Outcomes (8)
Change in Dynamic Imaging Grade of Swallowing Toxicity
Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up
Change in Functional Oral Intake Scale Score
Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up
Change in Standardized Swallowing Assessment Score
Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up
Change in Swallowing Quality of Life Questionnaire Score
Baseline, immediately after the 2-week intervention, and at 4- and 12-week follow-up
Change in Maximum Hyoid Displacement
Baseline and immediately after the 2-week intervention
- +3 more secondary outcomes
Other Outcomes (2)
Change in Pharyngeal Motor-Evoked Potential Amplitude
Baseline and immediately after the 2-week intervention
Change in Dentato-Thalamo-Cortical Functional Connectivity
Baseline and immediately after the 2-week intervention
Study Arms (2)
Active tTIS Group
EXPERIMENTALParticipants 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.
Sham tTIS Group
SHAM COMPARATORParticipants 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.
Interventions
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants, swallowing therapists, clinical outcome assessors, imaging personnel, and statisticians will be unaware of treatment allocation. The stimulation device will display only a coded treatment mode. The stimulation operator cannot be masked because the operator must select and administer the assigned active or sham program. The operator will not participate in swallowing rehabilitation, outcome assessment, data management, or statistical analysis and will use standardized interactions with participants.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
August 9, 2026
First Posted
August 14, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 30, 2029
Study Completion (Estimated)
March 1, 2030
Last Updated
August 14, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.