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Safety and Feasibility of Temporal Interference Brain Stimulation for Treatment in Psychiatric Disorders

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary and study completion dates: Oct 2025 to Oct 2026
    • Eligibility criteria revised
    • Study title expanded, about 5 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to validate if temporal interference brain stimulation (TIBS) is safe in healthy volunteers aged 20 to 65. The main questions it aims to answer are: * Is it safe to apply TIBS intervention to the left hippocampus in healthy participants? * Is it safe to apply TIBS intervention to the left insula in healthy participants? * Is it safe to apply TIBS intervention to the left anterior cingulate cortex in healthy participants? * Is it safe to apply TIBS intervention to the right inferior frontal cortex in healthy participants? Participants will: * Be Randomly allocated to either sham-first group or treat first-group, stratified by stimulated brain region, following a crossover-controlled experimental design * Complete baseline cognitive evaluations and mental status assessments, and undergo a baseline MRI scan on the same day * Receive stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of stimulation. * Complete post-intervention cognitive evaluations and mental status assessments, and undergo a post-intervention MRI scan on the same day
Trial Details
NCT Number NCT07179848
Lead Sponsor Taipei Veterans General Hospital, Taiwan
Conditions
(from sponsor)		 Health Adults, Temporal Interference Stimulation, Safety and Effectiveness, Crossover Study
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov