Magnetic Seizure Therapy for Bipolar Mania

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Completed

CT.gov ID

NCT03160664

Collaborator

(none)

Enrollment

Location

Arms

45.8

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder, Manic	Device: Magpro X100 + Option Device: ThymatronSystem Ⅳ Electroconvulsive System Other: treatment as usual (TAU)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Mar 3, 2021

Actual Study Completion Date :

Apr 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: magnetic seizure therapy 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 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. Other Names: magnetic seizure therapy Other: treatment as usual (TAU) Participants will engage in their inpatient treatment program as-usual.
Active Comparator: electroconvulsive therapy 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 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 Other Names: electroconvulsive therapy Other: treatment as usual (TAU) Participants will engage in their inpatient treatment program as-usual.

Arm

Intervention/Treatment

Experimental: magnetic seizure therapy

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

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.

Other Names:

magnetic seizure therapy

Other: treatment as usual (TAU)

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

Active Comparator: electroconvulsive therapy

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

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

Other Names:

electroconvulsive therapy

Other: treatment as usual (TAU)

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

Outcome Measures

Primary Outcome Measures

changes in the Young Mania Rating Scale [At baseline, 4-week follow-up, and 8-week follow-up]

Secondary Outcome Measures

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) [At baseline and 24 hours after the first treatment]
using single-pulse Transcranial Magnetic Stimulation (sTMS)
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)
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 Novel P300 [At baseline and 24 hours after the first treatment]
measured by electroencephalogram (EEG)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.