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.
This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% motor threshold (MT) intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil. Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
with 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).
The sham stimulation was performed using the same procedures, with the sham coil.
Tianjin Anding Hospital
Tianjin, China
RECRUITINGThe 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.
Time frame: baseline, week 2, week 4, week 8
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.
Time frame: weeks 2, week 4 and week 8
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.
Time frame: baseline, week 4, 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.
Time frame: baseline, week 2, week 4, week 8
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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Time frame: baseline, week 4, week 8
The change of scores of adverse events scale from baseline to week 4
The aim is to evaluate the adverse effects during the treatment.
Time frame: baseline, week 4