50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Completed

CT.gov ID

NCT03003156

Collaborator

(none)

Enrollment

Location

Arms

12.9

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Procedure: 25 Hz magnetic seizure therapy Procedure: 50 Hz magnetic seizure therapy	N/A

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. 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 25 Hz magnetic seizure therapy 10 treatment sessions of 25 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.	Procedure: 25 Hz magnetic seizure therapy 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.
Experimental: 50 Hz magnetic seizure therapy 10 treatment sessions of 50 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.	Procedure: 50 Hz magnetic seizure therapy 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.

Arm

Intervention/Treatment

Experimental: 25 Hz magnetic seizure therapy

10 treatment sessions of 25 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.

Procedure: 25 Hz magnetic seizure therapy

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.

Experimental: 50 Hz magnetic seizure therapy

10 treatment sessions of 50 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.

Procedure: 50 Hz magnetic seizure therapy

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.

Outcome Measures

Primary Outcome Measures

changes of The Positive and Negative Syndrome Scale (PANSS) [At baseline, 4-week follow-up]

Secondary Outcome Measures

changes of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [At baseline and 4-week follow-up]
seizure duration [at each treatment session, up to 4 weeks]
Adverse events [up to 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.