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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Temporal Interference Stimulation
  • Sham Temporal Interference Stimulation

Treatment groups

160 Participants
are divided into 2 treatment groups