50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia

Schizophrenia Clinical Trial

Official title:

50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003156
• Other study ID #: SHDC12014111a
• Status: Completed
• Phase: N/A
• First received: December 16, 2016
• Last updated: May 3, 2017
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• 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.

Related Conditions & MeSH terms

• Schizophrenia
• Seizures

Intervention

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.
• 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.

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