deep Transcranial Magnetic Stimulation (dTMS) -activedeep Transcranial Magnetic Stimulation (dTMS) -sham
deep Transcranial Magnetic Stimulation (dTMS) -active: 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).
deep Transcranial Magnetic Stimulation (dTMS) -sham: The sham stimulation was performed using the same procedures, with the sham coil.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
Confirmed diagnosis of bipolar depression;
* 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.
Exclusion Criteria:
* 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);
* pregnancy or lactation.
Primary outcome measure(s)
The change over time in the score of Hamilton Depression Rating Scale (HDRS-17). — baseline, week 2, week 4, week 8 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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