NCT06516991Completed
Task-State-Based Temporal Interference Stimulation (TI) to Improve Depression in Patients With Bipolar Disorder
Efficacy and Safety of Task-State-Based Temporal Interference Stimulation (TI) in Improving Depression in Patients With Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
The purpose of this study is to investigate the efficacy and safety of temporal interference stimulation (TI) in improving depressive episodes of bipolar disorder, to analyze the therapeutic principle of TI in bipolar disorder depressive episodes based on task state MRI scanning, and to explore the abnormal regulation mechanism of anhedonia neural circuit.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 18 Jul 2024
- Start date
- 16 Jul 2024
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Bipolar disorder
- NCT number
- NCT06516991
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 16 Jul 2024 to the primary completion date, 30 Sept 2024
- 1 site 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Co-morbid other psychiatric disorders, including affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
- History of a serious physical illness or a disease that may affect the central nervous system;
Age
- Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.
Who the study is looking for
- Aged 16-50 years, right-handed, and completed nine years of compulsory education;
- Meet the diagnostic criteria for bipolar disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- HAMD-17: \>17 points , assessed the presence of rapture deficits;
- Subject had not been treated with a mood stabilizer, or had previously used an antidepressants and currently off medication for ≥1 week;
- The subject/legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after being fully informed of the temporal interference stimulus (TI).
Age in the registry: 16 years to 38 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.