Magnetic Seizure Therapy for Schizophrenia
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: magnetic seizure therapy 10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks. |
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.
Other Names:
Other: treatment as usual (TAU)
Participants will engage in their inpatient treatment program as-usual.
|
| Active Comparator: electroconvulsive therapy 10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks. |
Device: ThymatronSystem Ⅳ 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 Names:
Other: treatment as usual (TAU)
Participants will engage in their inpatient treatment program as-usual.
|
Outcome Measures
Primary Outcome Measures
- changes of The Positive and Negative Syndrome Scale (PANSS) [At baseline, 4-week, 8-week]
Secondary Outcome Measures
- changes in motor threshold (MT) [At baseline and the day after the first treatment]
using single-pulse Transcranial Magnetic Stimulation (sTMS)
- changes in brain gamma-aminobutyric acid （GABA）levels [At baseline, the day after the first treatment, and at 4-week follow-up]
- changes in resting state network [At baseline, the day after the first treatment, and at 4-week follow-up]
measured by Magnetic Resonance Imaging (MRI)
- changes in auditory evoked potential (AEP) [At baseline and the day after the first treatment]
measured by electroencephalogram (EEG)
- changes in Novel P300 [At baseline and the day after the first treatment]
measured by electroencephalogram (EEG)
- changes in blood brain-derived neurotrophic factor (BDNF) [At baseline and at 4-week follow-up]
- changes in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [At baseline, 4-week, 8-week]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Mental Health Center | Shanghai | Shanghai | China | 200030 |
Sponsors and Collaborators
- Shanghai Mental Health Center
Investigators
- Principal Investigator: Chunbo Li, PHD, Shanghai Mental Health Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHDC12014111