Temporal interference stimulation for bipolar depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized interventional study comparing active temporal interference (TI) stimulation with a sham procedure in adults diagnosed with bipolar depression. Participants will undergo TI or sham sessions while clinical symptoms are tracked and neuroimaging (MRI) plus EEG are collected to explore underlying brain mechanisms. Eligible participants must meet DSM-5 criteria for bipolar depression, have a HAMD-17 score of 18 or higher and YMRS of 8 or lower, and be able to undergo medication washout if applicable. The goal is to generate both symptom outcome data and objective imaging markers to guide future intervention protocols.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Psychiatry, First Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Shaohua Hu, PhD
• Email: dorhushaohua@zju.edu.cn
• Phone: 0571-87232984

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.