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NCT Number: NCT07179848

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

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

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Key information

Conditions

Health Adults Crossover Study Safety and Effectiveness Temporal Interference Stimulation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location status: Recruiting

Location contact

Albert Chih-Chieh Yang, MD, PhD

CONTACT

[email protected]

+886-2-2826-7000

Albert Chih-Chieh Yang, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults from the community
  • Age between 20 and 65 years old
  • No diagnosis of severe psychiatric disorders
  • No family history of psychiatric diseases

Exclusion criteria

  • Age below 20 years old or above 65 years old
  • Currently prescribed any medication
  • Diagnosis of psychiatric disorders (e.g., Major Depressive Disorder, Bipolar Disorder, Schizophrenia)
  • Diagnosis of neurological disorders (e.g., Dementia, Stroke, Parkinson's disease)
  • History of substance abuse
  • Diagnosis of cancer or malignant tumors
  • Chronic kidney failure or undergoing hemodialysis
  • Pregnant or breastfeeding
  • Severe arrythmia, presence of pacemaker, or metal implants in the brain
  • Claustrophobia
  • History or family history of seizure
  • History of syncope
  • Organic brian disease, brian trauma, or history of neurosurgery
  • Received electroconvulsive therapy or repetitive transcranial magnetic stimulation within the past month
  • Skin disorders (e.g., dermatitis, psoriasis, eczema)
  • Currently participating in other clinical interventional trials
  • Presence of any metal implants or devices affected by electromagnetic fields

Treatment and study plan

Temporal Interference Stimulation - Treatment first

Device

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

Temporal Interference Stimulation - Sham first

Device

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

Primary outcomes

  1. Changes in NRS related to intervention

    Time frame: Baseline (before each stimulation session), midpoint during each session, immediately after each stimulation for 10 sessions (approximately 2 weeks), and 1 month after completion of all sessions.

    Numeric rating scale (NRS) will be used to evaluate the side effects, pain intensity, and other adverse events potentially related to the intervention, at baseline, during stimulation, immediately after each session, and at follow-up.

  2. Changes in VAS related to intervention

    Time frame: Baseline (before each stimulation session), midpoint during each session, immediately after each stimulation for 10 sessions (approximately 2 weeks), and 1 month after completion of all sessions.

    Visual analog scale (VAS) will be used to evaluate the side effects, pain intensity, and other adverse events potentially related to the intervention, at baseline, during stimulation, immediately after each session, and at follow-up.

  3. Changes in MMSE from baseline to post-intervention

    Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session

    Mini-Mental State Examination (MMSE) will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention. Cognitive function will be considered normal if the MMSE score is greater than 24.

  4. Changes in BAI from baseline to post-intervention

    Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation

    Beck Anxiety Inventory (BAI) will be administered to evaluate the mental status approximately 1 week before the first intervention and 1 week after the last intervention. Mental status will be considered stable if both BAI and BDI are less than 13.

  5. Changes in BDI from baseline to post-intervention

    Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation

    Beck Depression Inventory (BDI) will be administered to evaluate the mental status approximately 1 week before the first intervention and 1 week after the last intervention. Mental status will be considered stable if both BAI and BDI are less than 13.

  6. Changes in MRI from baseline to post-intervention

    Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation

    T1-weighted magnetic resonance imaging (T1-weighted MRI) and resting-state functional magnetic resonance imaging (resting-state fMRI) will be acquired to evaluate structural and functional brain alterations potentially related to the intervention. Imaging will be performed approximately 1 week before the first intervention and 1 week after the last intervention.

Secondary outcomes

  1. Changes in WCST score from baseline to post-intervention

    Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session

    Wisconsin Card Sorting Test (WCST) will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention.

  2. Changes in verbal fluency test from baseline to post-intervention

    Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session

    Verbal fluency test will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Chih-Chieh Yang, MD, PhD

CONTACT

[email protected]

+886-2-2826-7000

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

Phase I Clinical Trial of a New Non-invasive Deep Brain Stimulation Technique

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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