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

NCT07179848 | Recruiting Phase 1

• 2 other identifiers: 2024-04-001ANSTC 112-2321-B-A49-013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hippocampus; Temporal Interference Stimulation; Insula; Anterior Cingulate Cortex; Inferior Frontal Cortex

Outcome Measures

Primary Outcomes (6)

• Changes in NRS related to intervention

  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.

  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.

• Changes in VAS related to intervention

  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.

  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.

• Changes in MMSE from baseline to post-intervention

  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.

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

• Changes in BAI from baseline to post-intervention

  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.

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

• Changes in BDI from baseline to post-intervention

  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.

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

• Changes in MRI from baseline to post-intervention

  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.

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

Secondary Outcomes (2)

• Changes in WCST score from baseline to post-intervention

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

• Changes in verbal fluency test from baseline to post-intervention

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

Study Arms (8)

Hippocampus - Treatment first

EXPERIMENTAL

Device: Temporal Interference Stimulation - Treatment first

Hippocampus - Sham first

SHAM COMPARATOR

Device: Temporal Interference Stimulation - Sham first

Insula - Treatment first

EXPERIMENTAL

Device: Temporal Interference Stimulation - Treatment first

Insula - Sham first

SHAM COMPARATOR

Device: Temporal Interference Stimulation - Sham first

Anterior cingulate cortex - Treatment first

EXPERIMENTAL

Device: Temporal Interference Stimulation - Treatment first

Anterior cingulate cortex - Sham first

SHAM COMPARATOR

Device: Temporal Interference Stimulation - Sham first

Inferior frontal cortex - Treatment first

EXPERIMENTAL

Device: Temporal Interference Stimulation - Treatment first

Inferior frontal cortex - Sham first

SHAM COMPARATOR

Device: Temporal Interference Stimulation - Sham first

Interventions

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

Anterior cingulate cortex - Treatment first; Hippocampus - Treatment first; Inferior frontal cortex - Treatment first; Insula - Treatment first

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

Anterior cingulate cortex - Sham first; Hippocampus - Sham first; Inferior frontal cortex - Sham first; Insula - Sham first

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Central Study Contacts

Albert Chih-Chieh Yang, MD, PhD

CONTACT

+886-2-2826-7000; accyang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 18, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)