Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Schizophrenia

This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety among schizophrenia patients. Half of the participants will be randomized to MST group, while the other half will be randomized to receive electroconvulsive therapy (ECT).

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Device: Magpro X100; Other: Treatment as usual (TAU); Device: ThymatronSystem Ⅳ Electroconvulsive System

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.

However, MST and ECT may both works via alterations of cortical inhibition and default mode network.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. DSM-5 diagnosis of schizophrenia;
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 positive and negative syndrome scale (PANSS)[20] score ≥ 60;
4. informed consent in written form.

Exclusion Criteria:

1. 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. other conditions that investigators consider to be inappropriate to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; In addition to treatment as usual (TAU), participants are 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 intpatient 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.	Other: Treatment as usual (TAU); Participants will engage in their intpatient treatment program as-usual.; Device: ThymatronSystem Ⅳ Electroconvulsive System; In addition to treatment as usual (TAU), participants are 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Positive and Negative Syndrome Scale (PANSS)		At baseline and 4-week follow-up
changes in brain structure	measured by Magnetic Resonance Imaging (MRI)	At baseline, the 1 day after the first treatment, and at 4-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)		At baseline and 4-week follow-up
Changes in Clinical Global Impressions (CGI)		At baseline and 4-week follow-up
Changes in motor threshold (MT)	using single-pulse Transcranial Magnetic Stimulation (sTMS)	At baseline and the day after the first treatment
Changes in brain gamma-aminobutyric acid （GABA）levels	measured by Magnetic Resonance Spectroscopy (MRS)	At baseline, between the first treatment and the second treatment, and at 4-week follow-up
Changes in resting state network (RSN)	measured by Magnetic Resonance Imaging (MRI)	At baseline, the day after the first treatment, and at 4-week follow-up
Changes in auditory evoked potential (AEP)	measured by electroencephalogram (EEG)	At baseline and the day after the first treatment
Changes in novel P300 potential	measure by electroencephalogram (EEG)	At baseline and the day after the first treatment

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Jijun Wang, PHD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: electroconvulsive therapy; controlled trial; magnetic seizure therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Seizures
• Other Study ID Numbers: 14411961400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD data