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

NCT07179848 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-09

No results posted yet for this study

Summary

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

Conditions

  • Health Adults
  • Temporal Interference Stimulation
  • Safety and Effectiveness
  • Crossover Study

Interventions

DEVICE

Temporal Interference Stimulation - Treatment first

Receive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation

DEVICE

Temporal Interference Stimulation - Sham first

Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07179848 on ClinicalTrials.gov