NCT07924917Recruiting
Individualized Temporally Interfering Electrical Stimulation in Major Depressive Disorder
Closed-Loop Bio-Machine Interaction System and Applications in Psychiatric Diagnosis and Treatment
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
Temporally interfering (TI) electrical stimulation is a novel noninvasive neuromodulation technique with high spatial resolution. Although its effects on human brain function and behavior have been increasingly investigated, its clinical utility in major depressive disorder (MDD) has not been established. This trial aims to evaluate the efficacy and safety of TI electrical stimulation in MDD patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 3 Nov 2026
- Start date
- 11 Mar 2025
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- Tianjin Medical University General Hospital
- Diseases
- Depression
- NCT number
- NCT07924917
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 11 Mar 2025 to the primary completion date, 15 Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-65 with major depressive disorder who are in a depressive episode and have a HAMD-17 score of 17 or more. It tests a painless brain stimulation using electrical currents.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Major depressive disorder (DSM-5), currently in a depressive episode, with a HAMD-17 score of 17 or more.
- Earlier treatment
- No antidepressant in the two weeks before joining, or a stable ongoing antidepressant treatment judged by a psychiatrist. No ECT, TMS or other brain stimulation therapy in the past six months.
Main reasons for not taking part
- Any other psychiatric disorder besides major depressive disorder
- Brain injury, coma, brain disease or severe general illness
- Implanted device such as a cochlear implant or pacemaker
- Epileptic seizures, or epilepsy in the family
- Clear suicidal or violent impulsive behavior
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within the past six months;
Other illness
- History of any psychiatric disorder other than MDD;
- History of traumatic brain injury or coma;
- History of organic brain disease or severe systemic medical illness;
- History of cochlear implants, pacemakers, or other implanted brain devices;
- History of epileptic seizures or family history of epilepsy;
- History of alcohol use disorder or use of other psychoactive substances;
- Any condition precluding informed consent or compliance with study procedures.
Other
- Obvious suicidal or impulsive violent behavior;
- Participation in other interventional clinical trials;
Who the study is looking for
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for MDD, confirmed independently by two psychiatrists;
- Currently experiencing a depressive episode;
- Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17;
- Aged between 18-65 years;
- No restrictions on sex or gender;
- Attained at least junior high school education; lower education permitted if cognitive capacity is confirmed by a physician;
- Normal or corrected-to-normal vision and normal hearing;
- No use of antidepressant within two weeks prior to enrollment, or ongoing antidepressant treatment judged by a psychiatrist to be in a stable treatment phase;
- Ability to read and understand informed consent and self-report assessment scales;
- Willingness to participate in the study, with written informed consent provided by the participant or a legal guardian.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuzhou Neuropsychiatric Hospital Affiliated to Fujian Medical University | Fuzhou | China | Recruiting |
| Tianjin Anding Hospital | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.