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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Procedure: 25 Hz magnetic seizure therapy; Procedure: 50 Hz magnetic seizure therapy

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes of The Positive and Negative Syndrome Scale (PANSS)	At baseline, 4-week follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Chunbo Li, PHD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: cognition; schizophrenia; controlled trial; magnetic seizure therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Seizures
• Other Study ID Numbers: SHDC12014111a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share IPD data