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Completed

NCT Number: NCT03003156

50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia

This trial attempts to investigate whether the dosage (frequency) has an effect on the treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST, while the other half will be recruited to 50 Hz MST.

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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. Though high dose (frequency) MST is gaining popularity, there is no evidences supporting its superiority over low dose (frequency) MST either on efficacy, safety, or seizure quality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DSM-5 diagnosis of schizophrenia;
  • convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
  • the positive and negative syndrome scale (PANSS)[20] score ≥ 60;
  • informed consent in written form.

Exclusion criteria

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

Treatment and study plan

25 Hz magnetic seizure therapy

Procedure

In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 25 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.

50 Hz magnetic seizure therapy

Procedure

In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 50 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.

Primary outcomes

  1. changes of The Positive and Negative Syndrome Scale (PANSS)

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

Secondary outcomes

  1. changes of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

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

  2. seizure duration

    Time frame: at each treatment session, up to 4 weeks

  3. Adverse events

    Time frame: up to 4 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 26, 2016
Registry last updated
May 5, 2017

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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