Magnetic Seizure Therapy for Schizophrenia

S

Shanghai Mental Health Center

Status

Terminated

Conditions

Schizophrenia

Treatments

Other: treatment as usual (TAU)
Device: Magpro X100 + Option
Device: ThymatronSystem Ⅳ Electroconvulsive System

Study type

Interventional

Funder types

Other

Identifiers

NCT02746965
SHDC12014111

Details and patient eligibility

About

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).

Full 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.

Enrollment

79 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

79 participants in 2 patient groups

magnetic seizure therapy
Experimental group
Description:
10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.
Treatment:
Device: Magpro X100 + Option
Other: treatment as usual (TAU)
electroconvulsive therapy
Active Comparator group
Description:
10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.
Treatment:
Device: ThymatronSystem Ⅳ Electroconvulsive System
Other: treatment as usual (TAU)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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