Magnetic Seizure Therapy for Bipolar Mania

NCT ID: NCT03160664

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-04-26

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.

Conditions

Bipolar Disorder, Manic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

magnetic seizure therapy

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

Group Type: EXPERIMENTAL

Magpro X100 + Option

Intervention Type: 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.

treatment as usual (TAU)

Intervention Type: OTHER

Participants will engage in their inpatient treatment program as-usual.

electroconvulsive therapy

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

Group Type: ACTIVE_COMPARATOR

ThymatronSystem Ⅳ Electroconvulsive System

Intervention Type: 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

treatment as usual (TAU)

Intervention Type: OTHER

Participants will engage in their inpatient treatment program as-usual.

Interventions

Magpro X100 + Option

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.

Intervention Type: DEVICE

ThymatronSystem Ⅳ Electroconvulsive System

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

Intervention Type: DEVICE

treatment as usual (TAU)

Participants will engage in their inpatient treatment program as-usual.

Intervention Type: OTHER

Other Intervention Names

magnetic seizure therapy; electroconvulsive therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianhua Sheng, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38683612 (View on PubMed)

Other Identifiers

17411969900

Identifier Type: -

Identifier Source: org_study_id