Temporal interference stimulation for bipolar depression

Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression: a Randomized Controlled Study

This trial will test whether temporal interference brain stimulation can help adults with bipolar depression and uses MRI and EEG to see how the brain responds.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07021508 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with DSM-5 bipolar depression who are right-handed, have HAMD-17 ≥18 and YMRS ≤8, can consent, and can be medication-free or complete a brief washout are ideal candidates.

Not a fit: People with contraindications to MRI or to TI (for example intracranial metal, pacemakers, cochlear implants), current mania, or who cannot stop interfering medications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, TI could provide a noninvasive brain-stimulation option to reduce depressive symptoms and offer imaging markers to predict who will respond.

How similar studies have performed: Temporal interference stimulation is a novel human technique with limited direct clinical data, while other noninvasive methods like TMS and tDCS have shown mixed but sometimes positive results in depressive disorders.

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.

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Shaohua Hu, PhD

Conditions Bipolar Depression