Health AdultsPhase 1NCT07179848
Safety and Feasibility of Temporal Interference Brain Stimulation for Treatment in Psychiatric Disorders
A Phase 1 study testing Temporal Interference Stimulation - Treatment first in people with Health Adults and Temporal Interference Stimulation, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adults, Temporal Interference Stimulation, Safety and Effectiveness
- What is being tested?
- Temporal Interference Stimulation - Treatment first
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2025to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults from the community
- Age between 20 and 65 years old
- No diagnosis of severe psychiatric disorders
- No family history of psychiatric diseases
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Albert Chih-Chieh Yang, MD, PhD, +886-2-2826-7000, accyang@gmail.com
Albert Chih-Chieh Yang, MD, PhD
About this study
Official title: Phase I Clinical Trial of a New Non-invasive Deep Brain Stimulation Technique
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?
Read more
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
- Being tested
- Temporal Interference Stimulation - Treatment first, Temporal Interference Stimulation - Sham first
- Keywords
- Hippocampus, Temporal Interference Stimulation, Insula, Anterior Cingulate Cortex, Inferior Frontal Cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference Stimulation - Treatment firstDevice
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 firstDevice
Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation
| Study group | Role | What they receive |
|---|---|---|
| Hippocampus - Treatment first | Experimental | Not described Receives: Device: Temporal Interference Stimulation - Treatment first |
| Hippocampus - Sham first | Sham comparator | Not described Receives: Device: Temporal Interference Stimulation - Sham first |
| Insula - Treatment first | Experimental | Not described Receives: Device: Temporal Interference Stimulation - Treatment first |
| Insula - Sham first | Sham comparator | Not described Receives: Device: Temporal Interference Stimulation - Sham first |
| Anterior cingulate cortex - Treatment first | Experimental | Not described Receives: Device: Temporal Interference Stimulation - Treatment first |
| Anterior cingulate cortex - Sham first | Sham comparator | Not described Receives: Device: Temporal Interference Stimulation - Sham first |
| Inferior frontal cortex - Treatment first | Experimental | Not described Receives: Device: Temporal Interference Stimulation - Treatment first |
| Inferior frontal cortex - Sham first | Sham comparator | Not described Receives: Device: Temporal Interference Stimulation - Sham first |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
Verbal fluency test will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention.
Measured: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start26 Feb 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AdultsStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179848
- Sponsor's protocol ID
- 2024-04-001A
- Other IDs
- NSTC 112-2321-B-A49-013
- Status last verified
- Feb 2026
- First submitted
- 28 Aug 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the limited sample size, the risk of participant re-identification may be higher.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of a New Non-invasive Deep Brain Stimulation Technique
- ClinicalTrials.gov ID
- NCT07179848
- Acronym / sponsor ID
- 2024-04-001A
- Conditions
- Health Adults, Temporal Interference Stimulation, Safety and Effectiveness, Crossover Study
- Keywords
- Hippocampus, Temporal Interference Stimulation, Insula, Anterior Cingulate Cortex, Inferior Frontal Cortex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults from the community
- Age between 20 and 65 years old
- No diagnosis of severe psychiatric disorders
- No family history of psychiatric diseases
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal Interference Stimulation - Treatment firstReceive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation | Device | Anterior cingulate cortex - Treatment first, Hippocampus - Treatment first, Inferior frontal cortex - Treatment first, Insula - Treatment first |
| Temporal Interference Stimulation - Sham firstReceive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation | Device | Anterior cingulate cortex - Sham first, Hippocampus - Sham first, Inferior frontal cortex - Sham first, Insula - Sham first |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. Due to the limited sample size, the risk of participant re-identification may be higher.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Temporal Interference Stimulation - Treatment first in people with Health Adults and Temporal Interference Stimulation, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Chih-Chieh Yang, MD, PhD (+886-2-2826-7000, accyang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.