Magnetic Seizure Therapy for Bipolar Mania

October 29, 2023 updated by: Shanghai Mental Health Center

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

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).

Study Overview

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)

48

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

    • 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

Description

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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Participants will engage in their inpatient treatment program as-usual.
Active Comparator: 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.
Participants will engage in their inpatient treatment program as-usual.
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 in the Young Mania Rating Scale
Time Frame: At baseline, 4-week follow-up
At baseline, 4-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
Time Frame: At baseline and 4-week follow-up
At baseline and 4-week follow-up
changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame: At baseline and 4-week follow-up
At baseline and 4-week follow-up
changes in the Clinical Global Impression Scale (CGI)
Time Frame: At baseline and 4-week follow-up
At baseline and 4-week follow-up
changes in the motor threshold (MT)
Time Frame: At baseline and 24 hours after the first treatment
using single-pulse Transcranial Magnetic Stimulation (sTMS)
At baseline and 24 hours after the first treatment
changes in brain gamma-aminobutyric acid (GABA)levels
Time Frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
measured by Magnetic Resonance Spectroscopy (MRS)
At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in the resting state network
Time Frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
measured by Magnetic Resonance Imaging (MRI)
At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in auditory evoked potentials (AEP)
Time Frame: At baseline and 24 hours after the first treatment
measured by electroencephalogram (EEG)
At baseline and 24 hours after the first treatment
changes in the Novel P300
Time Frame: At baseline and 24 hours after the first treatment
measured by electroencephalogram (EEG)
At baseline and 24 hours after the first treatment

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jianhua Sheng, PhD, Shanghai Mental Health Center

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)

July 1, 2017

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 29, 2023

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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