Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
Tianjin Anding Hospital
100 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria5
- 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.
Interventions
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.
Locations(1)
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NCT06524505