50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
25 Hz magnetic seizure therapy
50 Hz magnetic seizure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring magnetic seizure therapy, schizophrenia, controlled trial, cognition
Eligibility Criteria
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.
Sites / Locations
- Shanghai Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
25 Hz magnetic seizure therapy
50 Hz magnetic seizure therapy
Arm Description
10 treatment sessions of 25 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.
10 treatment sessions of 50 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.
Outcomes
Primary Outcome Measures
changes of The Positive and Negative Syndrome Scale (PANSS)
Secondary Outcome Measures
changes of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
seizure duration
Adverse events
Full Information
NCT ID
NCT03003156
First Posted
December 16, 2016
Last Updated
May 3, 2017
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT03003156
Brief Title
50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia
Official Title
50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
magnetic seizure therapy, schizophrenia, controlled trial, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25 Hz magnetic seizure therapy
Arm Type
Experimental
Arm Description
10 treatment sessions of 25 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.
Arm Title
50 Hz magnetic seizure therapy
Arm Type
Experimental
Arm Description
10 treatment sessions of 50 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.
Intervention Type
Procedure
Intervention Name(s)
25 Hz magnetic seizure therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
50 Hz magnetic seizure therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes of The Positive and Negative Syndrome Scale (PANSS)
Time Frame
At baseline, 4-week follow-up
Secondary Outcome Measure Information:
Title
changes of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame
At baseline and 4-week follow-up
Title
seizure duration
Time Frame
at each treatment session, up to 4 weeks
Title
Adverse events
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunbo Li, PHD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD data
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50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia
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