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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnetic seizure therapy | Experimental | 8-10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks. |
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| electroconvulsive therapy | Active Comparator | 8-10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magpro X100 + Option | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the Young Mania Rating Scale | At baseline, 4-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS) | At baseline and 4-week follow-up | |
| changes in the Montgomery Åsberg Depression Rating Scale (MADRS) | At baseline and 4-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhua Sheng, PHD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38683612 | Derived | Chen S, Sheng J, Yang F, Qiao Y, Wang W, Wen H, Yang Q, Chen X, Tang Y. Magnetic Seizure Therapy vs Modified Electroconvulsive Therapy in Patients With Bipolar Mania: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247919. doi: 10.1001/jamanetworkopen.2024.7919. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| ThymatronSystem Ⅳ Electroconvulsive System | Device | 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 |
|
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| treatment as usual (TAU) | Other | Participants will engage in their inpatient treatment program as-usual. |
|
| changes in the Clinical Global Impression Scale (CGI) | At baseline and 4-week follow-up |
| changes in the motor threshold (MT) | using single-pulse Transcranial Magnetic Stimulation (sTMS) | At baseline and 24 hours after the first treatment |
| changes in brain gamma-aminobutyric acid (GABA)levels | measured by Magnetic Resonance Spectroscopy (MRS) | 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) | At baseline, 24 hours after the first treatment, and at 4-week follow-up |
| changes in auditory evoked potentials (AEP) | measured by electroencephalogram (EEG) | At baseline and 24 hours after the first treatment |
| changes in the Novel P300 | measured by electroencephalogram (EEG) | At baseline and 24 hours after the first treatment |