Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called temporal interference stimulation to see if it can help people with bipolar depression feel better. The researchers want to understand how this treatment works in the brain using special imaging techniques. They hope to find effective ways to treat depressive episodes in bipolar disorder and provide guidance on predicting how well the treatment might work for individuals.

To participate in this trial, you must be at least 18 years old, right-handed, and have a specific level of depression as measured by a standard questionnaire. You should not have any metallic implants in your body that could interfere with the treatment or MRI scans, and you shouldn’t have a history of certain other mental health treatments or disorders. If you decide to join, you’ll undergo the treatment and have regular check-ins to monitor your progress. This research is currently looking for participants, and your involvement could help advance new options for managing bipolar depression.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • right-handed, and have completed nine years of compulsory education;
• • Meet the diagnostic criteria for bipolar depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
• • ≥18 points on the Hamilton Depression Inventory (HAMD- 17);
• • ≤8 points on the Young's Mania Rating Scale (YMRS);
• • Subjects who have not been treated with psychiatric medication, or those who have been treated with medication are required to undergo medication washout within 2 weeks before randomization;
• • Subjects/legal guardians are willing to cooperate with the treatment and sign an informed consent form after they have fully understood the Temporal Interference Stimulation (TI).
• Exclusion Criteria:
• • Contraindications to magnetic resonance scanning (MRI) 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);
• • Prior or current electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), transcranial direct current therapy (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation;
• • Pregnant and lactating women, and women of childbearing age with a positive urine pregnancy;
• • Possesses a diagnosis of another major psychiatric disorder that has been assessed by the study investigator as a major disorder that results in more impairment than a diagnosis of bipolar disorder;
• • Co-morbid other psychiatric disorders, including obsessive-compulsive disorder, personality disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.; Has active suicidal ideation (≥ 4 points on item 10 of the MADRS);
• • Risk of serious injury to self or others;
• • History of serious physical illness or disease that may affect the central nervous system;
• • Risk of neurologic disorders or seizures, such as previous craniosynostosis, cranial trauma, abnormal electroencephalograms, magnetic resonance evidence of structural abnormalities of the brain, or family history of epilepsy.