Magnetic Seizure Therapy for Bipolar Mania

Shanghai Mental Health Center

Status: Completed

Conditions: Bipolar Disorder, Manic

Treatments: Device: Magpro X100 + Option; Other: treatment as usual (TAU); Device: ThymatronSystem Ⅳ Electroconvulsive System

Study type: Interventional

Funder types: Other

Identifiers

NCT03160664

17411969900

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
3. the Young Mania Rating Scale (YMRS) score ≥ 10;
4. informed consent in written form.

Exclusion criteria

1. primary diagnosis of other mental disorders;
2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
4. failure to respond to an adequate trial of ECT lifetime;
5. are pregnant or intend to get pregnant during the study;
6. Unremovable metal implants.
7. other conditions that investigators consider to be inappropriate to participate in this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

magnetic seizure therapy

Experimental group

Description:

8-10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.

Treatment:

Device: Magpro X100 + Option

Other: treatment as usual (TAU)

electroconvulsive therapy

Active Comparator group

Description:

8-10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.

Treatment:

Device: ThymatronSystem Ⅳ Electroconvulsive System

Other: treatment as usual (TAU)