NCT07766668Not yet recruiting
Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia
Individualized Transcranial Temporal Interference Stimulation Targeting the Dentato-Thalamo-Cortical Pathway for Post-Stroke Dysphagia: A Randomized, Double-Blind, Sham-Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 9 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Zhejiang University
- Diseases
- Stroke
- NCT number
- NCT07766668
What you commit to
- Study type: Interventional
- Planned participants: 112
- From 1 Sept 2026 to the primary completion date, 30 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Intracranial metallic material, implanted electronic device, cochlear implant, or another contraindication to transcranial temporal interference stimulation, magnetic resonance imaging, or transcranial magnetic stimulation
Other illness
- History of epilepsy, seizure after the index stroke, unexplained loss of consciousness, or current use of medication considered to confer an unacceptable seizure risk
- Severe cognitive, behavioral, or language impairment that prevents participation despite supported communication
- Major scalp disease at the planned electrode sites
- Any other condition considered unsafe or unsuitable by the investigator
Other
- Tracheostomy, current mechanical ventilation, uncontrolled pneumonia, severe hypoxemia, or hemodynamic instability
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.