- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160664
Magnetic Seizure Therapy for Bipolar Mania
Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200030
- Shanghai Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
- convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
- the Young Mania Rating Scale (YMRS) score ≥ 10;
- informed consent in written form.
Exclusion Criteria:
- primary 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;
- Unremovable metal implants.
- 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: magnetic seizure therapy
8-10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.
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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:
Participants will engage in their inpatient treatment program as-usual.
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Active Comparator: electroconvulsive therapy
8-10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.
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Participants will engage in their inpatient treatment program as-usual.
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in the Young Mania Rating Scale
Time Frame: At baseline, 4-week follow-up
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At baseline, 4-week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
Time Frame: At baseline and 4-week follow-up
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At baseline and 4-week follow-up
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changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame: At baseline and 4-week follow-up
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At baseline and 4-week follow-up
|
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changes in the Clinical Global Impression Scale (CGI)
Time Frame: At baseline and 4-week follow-up
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At baseline and 4-week follow-up
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changes in the motor threshold (MT)
Time Frame: At baseline and 24 hours after the first treatment
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using single-pulse Transcranial Magnetic Stimulation (sTMS)
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At baseline and 24 hours after the first treatment
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changes in brain gamma-aminobutyric acid (GABA)levels
Time Frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
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measured by Magnetic Resonance Spectroscopy (MRS)
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At baseline, 24 hours after the first treatment, and at 4-week follow-up
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changes in the resting state network
Time Frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
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measured by Magnetic Resonance Imaging (MRI)
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At baseline, 24 hours after the first treatment, and at 4-week follow-up
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changes in auditory evoked potentials (AEP)
Time Frame: At baseline and 24 hours after the first treatment
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measured by electroencephalogram (EEG)
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At baseline and 24 hours after the first treatment
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changes in the Novel P300
Time Frame: At baseline and 24 hours after the first treatment
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measured by electroencephalogram (EEG)
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At baseline and 24 hours after the first treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jianhua Sheng, PhD, Shanghai Mental Health Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17411969900
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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