Magnetic Seizure Therapy for Bipolar Mania

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients

Conditions
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Bipolar Disorder, Manic

Intervention / Treatment
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* Device: Magpro X100 + Option
* Device: ThymatronSystem Ⅳ Electroconvulsive System
* Other: treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-5 diagnosis of bipolar I disorder and currently in a manic episode; convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics; the Young Mania Rating Scale (YMRS) score ≥ 10; informed consent in written form. Exclusion Criteria: primary diagnosis of other mental disorders; severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency; present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants; failure to respond to an adequate trial of ECT lifetime; are pregnant or intend to get pregnant during the study; Unremovable metal implants. other conditions that investigators consider to be inappropriate to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magnetic seizure therapy<br>8-10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks. | Device: Magpro X100 + Option<br>* 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.<br>* Other names: magnetic seizure therapy;Other: treatment as usual (TAU)<br>* Participants will engage in their inpatient treatment program as-usual.<br>|
| Active Comparator: electroconvulsive therapy<br>8-10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks. | Device: ThymatronSystem Ⅳ Electroconvulsive System<br>* 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<br>* Other names: electroconvulsive therapy;Other: treatment as usual (TAU)<br>* Participants will engage in their inpatient treatment program as-usual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the Young Mania Rating Scale |  | At baseline, 4-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic seizure therapy, electroconvulsive therapy, bipolar mania, cognition, randomized controlled trial