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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02746965
Other study ID # SHDC12014111
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date July 30, 2018

Study information

Verified date January 2019
Source Shanghai Mental Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 79
Est. completion date July 30, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Shanghai Mental Health Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes of The Positive and Negative Syndrome Scale (PANSS) At baseline, 4-week, 8-week
Secondary changes in motor threshold (MT) using single-pulse Transcranial Magnetic Stimulation (sTMS) At baseline and the day after the first treatment
Secondary changes in brain gamma-aminobutyric acid (GABA)levels At baseline, the day after the first treatment, and at 4-week follow-up
Secondary changes in resting state network measured by Magnetic Resonance Imaging (MRI) At baseline, the day after the first treatment, and at 4-week follow-up
Secondary changes in auditory evoked potential (AEP) measured by electroencephalogram (EEG) At baseline and the day after the first treatment
Secondary changes in Novel P300 measured by electroencephalogram (EEG) At baseline and the day after the first treatment
Secondary changes in blood brain-derived neurotrophic factor (BDNF) At baseline and at 4-week follow-up
Secondary changes in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) At baseline, 4-week, 8-week
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