Magnetic Seizure Therapy for Schizophrenia

May 5, 2022 updated by: Shanghai Mental Health Center
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

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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 + 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.
Other: treatment as usual (TAU)
Participants will engage in their inpatient treatment program as-usual.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes of The Positive and Negative Syndrome Scale (PANSS)
Time Frame: At baseline, 4-week, 8-week
At baseline, 4-week, 8-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in motor threshold (MT)
Time Frame: At baseline and the day after the first treatment
using single-pulse Transcranial Magnetic Stimulation (sTMS)
At baseline and the day after the first treatment
changes in resting state network
Time Frame: At baseline, the day after the first treatment, and at 4-week follow-up
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)
Time Frame: At baseline and the day after the first treatment
measured by electroencephalogram (EEG)
At baseline and the day after the first treatment
changes in Novel P300
Time Frame: At baseline and the day after the first treatment
measured by electroencephalogram (EEG)
At baseline and the day after the first treatment
changes in brain gamma-aminobutyric acid （GABA）levels
Time Frame: At baseline, the day after the first treatment, and at 4-week follow-up
At baseline, the day after the first treatment, and at 4-week follow-up
changes in blood brain-derived neurotrophic factor (BDNF)
Time Frame: At baseline and at 4-week follow-up
At baseline and at 4-week follow-up
changes in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: At baseline, 4-week, 8-week
At baseline, 4-week, 8-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Principal Investigator: Chunbo Li, PHD, Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC12014111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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