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.
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);
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;
Parallel
Temporal Interference Stimulation
DeviceA non-invasive, non-invasive method of deep brain electrical stimulation utilizing high-frequency electric field interactions to produce a low-frequency envelope to modulate neural activity.
Sham Temporal Interference Stimulation
DeviceThe same machine was used as the temporal Interferenc real stimulus, with current creep only 20 seconds before stimulus onset to simulate the real stimulus sensation.
Montgomery-Asberg Depression Rating Scale（MADRS）
Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. MADRS has a minimum value of 0 and a maximum value of 60, with larger scores representing poorer results.
Hamilton Depression Scale（HAMD-17)
The Hamilton Depression Scale（HAMD-17) was used to assess the extent of the patient's depressive episodes, with higher scores representing more severe depression, and this scale was used to monitor the patient's improvement in depression before and after treatment. HAMD-17 has a minimum value of 0 and a maximum value of 52, with larger scores representing poorer results.
Hamilton Anxiety Scale（HAMA）
The Hamilton Anxiety Scale is primarily used for the assessment of anxiety levels, and has 14 items, each of which has a 0-4 scale, with anxiety possible above a score of 7. HAMA has a minimum value of 0 and a maximum value of 56, with larger scores representing poorer results. The higher the score, the more severe the anxiety.
Young Mania Rating Scale（YMRS）
The Young Mania Rating Scale is mainly used to assess the manic symptoms of the subjects before and after the treatment, there are 11 items, each symptom has a working scale, divided into 5 levels, the level score of each item is different, most of them are 0-4, in which the 5th, 6th, 8th and 9th items are scored as 0, 2, 4, 6, 8, and the higher the total score of the subject the more serious the degree of mania. YMRS has a minimum value of 0 and a maximum value of 60, with larger scores representing poorer results.
Snaith-Hamilton Pleasure Scale（SHAPS）
The Snaith-Hamilton Pleasure Scale is a self-report scale that assesses the degree of the subject's pleasure deficit; the higher the score, the more severe their pleasure deficit. The scale was used to assess the degree of improvement in the patients' pleasure deficit before and after treatment. The minimum value of SHAPS is 14 and the maximum value is 56, with larger scores representing poorer results.
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