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Completed

NCT Number: NCT03160664

Magnetic Seizure Therapy for Bipolar Mania

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).

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magpro X100 + Option

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.

Other names: magnetic seizure therapy

ThymatronSystem Ⅳ Electroconvulsive System

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

Other names: electroconvulsive therapy

Treatment as usual (TAU)

Other

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

Primary outcomes

  1. changes in the Young Mania Rating Scale

    Time frame: At baseline, 4-week follow-up

Secondary outcomes

  1. changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)

    Time frame: At baseline and 4-week follow-up

  2. changes in the Montgomery Åsberg Depression Rating Scale (MADRS)

    Time frame: At baseline and 4-week follow-up

  3. changes in the Clinical Global Impression Scale (CGI)

    Time frame: At baseline and 4-week follow-up

  4. changes in the motor threshold (MT)

    Time frame: At baseline and 24 hours after the first treatment

    using single-pulse Transcranial Magnetic Stimulation (sTMS)

  5. 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)

  6. 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)

  7. changes in auditory evoked potentials (AEP)

    Time frame: At baseline and 24 hours after the first treatment

    measured by electroencephalogram (EEG)

  8. changes in the Novel P300

    Time frame: At baseline and 24 hours after the first treatment

    measured by electroencephalogram (EEG)

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 19, 2017
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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