NCT07021508 Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression

Trial Parameters

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Brief Summary

The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the corresponding neuroimaging mechanisms using magnetic resonance and electroencephalogram to provide novel intervention protocols and objective indicators of efficacy prediction for depressive episodes in bipolar disorder.

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 metal

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