Temporal Interference Brain Stimulation Phase I Clinical Trial

Not Applicable

Recruiting

• Conditions: Health Adults; Temporal Interference Stimulation; Safety and Effectiveness; Crossover Study

• Registration Number: NCT07179848
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-26
• Study First Submitted: 2025-08-28
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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, brain trauma, or history of neurosurgery
• Received electroconvulsive therapy or repetitive transcranial magnetic stimulation within the past month
• Skin disoreders (e.g., dermatitis, psoriasis, eczema)
• Currently participating in other clinical interventional trials
• Presence of any metal implants or devices affected by electromagnetic fields

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in MRI from baseline to post-intervention	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.
Changes in NRS related to intervention	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.
Changes in VAS related to intervention	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.
Changes in MMSE from baseline to post-intervention	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.
Changes in BAI from baseline to post-intervention	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.
Changes in BDI from baseline to post-intervention	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan