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

NCT ID: NCT07179848

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2026-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Health Adults Temporal Interference Stimulation Safety and Effectiveness Crossover Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hippocampus - Treatment first

Group Type EXPERIMENTAL

Temporal Interference Stimulation - Treatment first

Intervention Type DEVICE

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

Hippocampus - Sham first

Group Type SHAM_COMPARATOR

Temporal Interference Stimulation - Sham first

Intervention Type DEVICE

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

Insula - Treatment first

Group Type EXPERIMENTAL

Temporal Interference Stimulation - Treatment first

Intervention Type DEVICE

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

Insula - Sham first

Group Type SHAM_COMPARATOR

Temporal Interference Stimulation - Sham first

Intervention Type 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 - Treatment first

Group Type EXPERIMENTAL

Temporal Interference Stimulation - Treatment first

Intervention Type 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 - Sham first

Group Type SHAM_COMPARATOR

Temporal Interference Stimulation - Sham first

Intervention Type DEVICE

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

Inferior frontal cortex - Treatment first

Group Type EXPERIMENTAL

Temporal Interference Stimulation - Treatment first

Intervention Type DEVICE

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

Inferior frontal cortex - Sham first

Group Type SHAM_COMPARATOR

Temporal Interference Stimulation - Sham first

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Albert Chih-Chieh Yang, MD, PhD

Role: CONTACT

+886-2-2826-7000

Facility Contacts

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Albert Chih-Chieh Yang, MD, PhD

Role: primary

+886-2-2826-7000

Other Identifiers

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NSTC 112-2321-B-A49-013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-04-001A

Identifier Type: -

Identifier Source: org_study_id

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