The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatme… (NCT06826469) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Efficacy and Safety of Task-state-based Temporal Interference Stimulation (TI) in the Treatment of Patients With Depression
China43 participantsStarted 2026-06
Plain-language summary
This study intends to investigate the intervention efficacy of temporal interference stimulation (TI) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of TI improvement in depressed patients using pre- and post-treatment magnetic resonance.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18-50 years old, right-handed, and completed nine years of compulsory education;
. Met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depression;
. HAMD-17≥18;
. Subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks;
. The subject/ legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (TI).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called 'task-state-based Temporal Interference Stimulation' — can you explain what that means in practice, and how it's different from other brain stimulation treatments like TMS or ECT that I might already know about?
2The trial is listed as 'not yet recruiting,' so it hasn't started enrolling patients yet — how long do you think it might be before it opens, and would waiting for it delay any treatment I should be starting now?
3Since this study is listed as Phase NA, which sometimes means it's a very early or device-based feasibility study, what does that tell us about how much is already known about the safety and effectiveness of this type of stimulation for depression?
4The main thing being measured is the Hamilton Depression Scale score — can you help me understand what kind of improvement on that scale would actually be meaningful for my day-to-day life, and whether the trial is designed to compare this approach against standard treatments?
5Given that this trial hasn't started yet and my diagnosis is recent, would you recommend I try established treatments first, and could doing so affect whether I'd even be eligible for this study later on?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hamilton Depression Scale（HAMD-17)
Timeframe: 0-5 days
Trial details
NCT IDNCT06826469
SponsorFirst Affiliated Hospital of Zhejiang University
. Co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
. Severe suicidal ideation or behavior;
. History of a serious physical illness or a disease that may affect the central nervous system;
. Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;
. Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);
. Those who have received or are receiving electroconvulsive therapy (ECT ), modified electroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments;
. Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.