This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety for bipolar mania. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).
Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT). Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks
Participants will engage in their inpatient treatment program as-usual.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
changes in the Young Mania Rating Scale
Time frame: At baseline, 4-week follow-up
changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
Time frame: At baseline and 4-week follow-up
changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
Time frame: At baseline and 4-week follow-up
changes in the Clinical Global Impression Scale (CGI)
Time frame: At baseline and 4-week follow-up
changes in the motor threshold (MT)
using single-pulse Transcranial Magnetic Stimulation (sTMS)
Time frame: At baseline and 24 hours after the first treatment
changes in brain gamma-aminobutyric acid （GABA）levels
measured by Magnetic Resonance Spectroscopy (MRS)
Time frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in the resting state network
measured by Magnetic Resonance Imaging (MRI)
Time frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in auditory evoked potentials (AEP)
measured by electroencephalogram (EEG)
Time frame: At baseline and 24 hours after the first treatment
changes in the Novel P300
measured by electroencephalogram (EEG)
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Time frame: At baseline and 24 hours after the first treatment