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Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia

Study acronym: DENTIS-PSD
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Zhejiang University

Record History

  1. Primary endpoint(s) modified Enrollment increased: 88 → 112 participants · Eligibility criteria expanded, about 44 words · Secondary endpoints: details revised at 8 of 8 entries Show 3 more changesShow less
    • Enrollment increased: 88 → 112 participants
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 8 of 8 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Zhejiang University
149 trials monitored
See 4 trials at risk
Stroke
3,289 trials monitored
See 141 trials at risk
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 Details
NCT Number NCT07766668
Lead Sponsor Zhejiang University
Conditions Deglutition Disorders, Ischemic Stroke
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov