Temporal interference brain stimulation safety for psychiatric targets
Phase I Clinical Trial of a New Non-invasive Deep Brain Stimulation Technique
PHASE1 · Taipei Veterans General Hospital, Taiwan · NCT07179848
This project will try a new noninvasive brain stimulation called temporal interference stimulation in healthy adults aged 20–65 to see if it's safe when applied to four brain regions (left hippocampus, left insula, left anterior cingulate cortex, and right inferior frontal cortex).
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan (other gov) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07179848 on ClinicalTrials.gov |
What this trial studies
Healthy adults aged 20–65 are randomized, stratified by target region, to a crossover design that gives either sham stimulation first or active temporal interference stimulation first. Participants complete baseline cognitive and mental-status testing and an MRI, then receive five consecutive days of stimulation, a two-day washout, and five more days of stimulation. The protocol targets the left hippocampus, left insula, left anterior cingulate cortex, and right inferior frontal cortex to evaluate safety and tolerability. Primary outcomes focus on adverse events and tolerability, with exploratory cognitive and imaging measures collected.
Who should consider this trial
Good fit: Ideal candidates are healthy adults 20–65 with no major psychiatric or neurological diagnoses, not taking prescription medications, not pregnant or breastfeeding, and without metal brain implants or a history of seizures.
Not a fit: People with active psychiatric or neurological disorders, those on medications, pregnant or breastfeeding individuals, or anyone with pacemakers, brain implants, seizure history, or claustrophobia are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If shown safe, this approach could enable development of noninvasive methods to target deep brain regions involved in psychiatric disorders.
How similar studies have performed: Temporal interference stimulation is a novel technique with promising animal data and limited early human safety work, but it is not yet widely proven for treating psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Albert Chih-Chieh Yang, MD, PhD
- Email: accyang@gmail.com
- Phone: +886-2-2826-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Health Adults, Temporal Interference Stimulation, Safety and Effectiveness, Crossover Study, Hippocampus, Insula, Anterior Cingulate Cortex, Inferior Frontal Cortex