The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. We hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.
age between 18 and 65 years;
a 17-item Hamilton Depression Rating Scale (HDRS-17) score >= 17,
a stable pharmacological regimen maintained for at least 4 weeks prior to the beginning of the treatment phase ;
for participants who had previously received antidepressant therapy, a minimum 4-week washout period followed by re-evaluation.
a lifetime history of other psychiatric disorders, neurological diseases, or severe brain injury;
receipt of electroconvulsive therapy, rTMS, transcranial direct current stimulation, transcranial alternating current stimulation, or other neurostimulation treatments within the previous 3 months;
contraindications to magnetic stimulation, including epilepsy, cardiovascular disorders, or metallic implants in the head;
the presence of hypomanic/manic symptoms at baseline or a score greater than 12 on the Young Mania Rating Scale (YMRS);
Parallel
deep Transcranial Magnetic Stimulation (dTMS) -active
Devicewith the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).
deep Transcranial Magnetic Stimulation (dTMS) -sham
DeviceThe sham stimulation was performed using the same procedures, with the sham coil.
The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).
The aim is to explore whether deep Transcranial Magnetic Stimulation (dTMS) combined with Pharmacological treatment could alleviate the severity of depressive symptoms as measured with HDRS-17 in bipolar depression after 4-week treatment. Hamilton Depression Rating Scale (HDRS-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.
Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.
The aim is to evaluate the response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.
The change of scores in MATRICS Consensus Cognitive Battery(MCCB)
The aim is to observe whether active-stimuli in addition to pharmacological treatment will improve the cognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline, week 4 and week 8.
The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
The aim is to explore whether dTMS combined with Pharmacological treatment could alleviate the severity of anxious symptoms as measured with HAMA in bipolar depression after 4-week treatment. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of symptoms of anxiety. Higher total score of the scale means more severe anxious symptoms.
The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood
The aim is to investigate the change of Brain Derived Neurotrophic Factor (BDNF) level in peripheral blood as active stimuli in addition to regular medical treatment after 4 weeks of treatment compared to sham stimuli, and EDTA tubes were used to collect 5ml of peripheral blood at baseline, weeks 4, and 8 before feeding. The plasma was extracted after centrifugation, and the concentration of BDNF in plasma was detected by ELISA.
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