Magnetic Seizure Therapy for Bipolar Mania

Not Applicable

Completed

• Conditions: Bipolar Disorder, Manic
• Interventions: Device: Magpro X100 + Option; Device: ThymatronSystem Ⅳ Electroconvulsive System; Other: treatment as usual (TAU)

• Registration Number: NCT03160664
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Study Start: 2017-07-01
• Primary Completion: 2021-03-03
• Study Completion: 2021-04-26
• Status Verified: 2021-09
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
magnetic seizure therapy	treatment as usual (TAU)	8-10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.
magnetic seizure therapy	Magpro X100 + Option	8-10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.
electroconvulsive therapy	ThymatronSystem Ⅳ Electroconvulsive System	8-10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.
electroconvulsive therapy	treatment as usual (TAU)	8-10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.

Primary Outcome Measures

Name	Time	Method
changes in the Young Mania Rating Scale	At baseline, 4-week follow-up

Secondary Outcome Measures

Name	Time	Method
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 motor threshold (MT)	At baseline and 24 hours after the first treatment	using single-pulse Transcranial Magnetic Stimulation (sTMS)
changes in the Novel P300	At baseline and 24 hours after the first treatment	measured by electroencephalogram (EEG)
changes in the resting state network	At baseline, 24 hours after the first treatment, and at 4-week follow-up	measured by Magnetic Resonance Imaging (MRI)
changes in auditory evoked potentials (AEP)	At baseline and 24 hours after the first treatment	measured by electroencephalogram (EEG)
changes in the Clinical Global Impression Scale (CGI)	At baseline and 4-week follow-up
changes in brain gamma-aminobutyric acid （GABA）levels	At baseline, 24 hours after the first treatment, and at 4-week follow-up	measured by Magnetic Resonance Spectroscopy (MRS)

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China