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Magnetic Seizure Therapy for Bipolar Mania

Primary Purpose

Bipolar Disorder, Manic

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magpro X100 + Option
ThymatronSystem Ⅳ Electroconvulsive System
treatment as usual (TAU)
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder, Manic focused on measuring magnetic seizure therapy, electroconvulsive therapy, bipolar mania, cognition, randomized controlled trial

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
  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 Young Mania Rating Scale (YMRS) score ≥ 10;
  4. informed consent in written form.

Exclusion Criteria:

  1. primary 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. Unremovable metal implants.
  7. 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

Active Comparator

Arm Label

magnetic seizure therapy

electroconvulsive therapy

Arm Description

10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.

10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.

Outcomes

Primary Outcome Measures

changes in the Young Mania Rating Scale

Secondary Outcome Measures

changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
changes in the Clinical Global Impression Scale (CGI)
changes in the motor threshold (MT)
using single-pulse Transcranial Magnetic Stimulation (sTMS)
changes in brain gamma-aminobutyric acid （GABA）levels
measured by Magnetic Resonance Spectroscopy (MRS)
changes in the resting state network
measured by Magnetic Resonance Imaging (MRI)
changes in auditory evoked potentials (AEP)
measured by electroencephalogram (EEG)
changes in the Novel P300
measured by electroencephalogram (EEG)

Full Information

First Posted
May 14, 2017
Last Updated
September 21, 2021
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03160664
Brief Title
Magnetic Seizure Therapy for Bipolar Mania
Official Title
Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 3, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety for bipolar mania. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Manic
Keywords
magnetic seizure therapy, electroconvulsive therapy, bipolar mania, cognition, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
magnetic seizure therapy
Arm Type
Experimental
Arm Description
10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.
Arm Title
electroconvulsive therapy
Arm Type
Active Comparator
Arm Description
10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.
Intervention Type
Device
Intervention Name(s)
Magpro X100 + Option
Other Intervention Name(s)
magnetic seizure therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ThymatronSystem Ⅳ Electroconvulsive System
Other Intervention Name(s)
electroconvulsive therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
treatment as usual (TAU)
Intervention Description
Participants will engage in their inpatient treatment program as-usual.
Primary Outcome Measure Information:
Title
changes in the Young Mania Rating Scale
Time Frame
At baseline, 4-week follow-up, and 8-week follow-up
Secondary Outcome Measure Information:
Title
changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
Time Frame
At baseline and 4-week follow-up
Title
changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame
At baseline and 4-week follow-up
Title
changes in the Clinical Global Impression Scale (CGI)
Time Frame
At baseline and 4-week follow-up
Title
changes in the motor threshold (MT)
Description
using single-pulse Transcranial Magnetic Stimulation (sTMS)
Time Frame
At baseline and 24 hours after the first treatment
Title
changes in brain gamma-aminobutyric acid （GABA）levels
Description
measured by Magnetic Resonance Spectroscopy (MRS)
Time Frame
At baseline, 24 hours after the first treatment, and at 4-week follow-up
Title
changes in the resting state network
Description
measured by Magnetic Resonance Imaging (MRI)
Time Frame
At baseline, 24 hours after the first treatment, and at 4-week follow-up
Title
changes in auditory evoked potentials (AEP)
Description
measured by electroencephalogram (EEG)
Time Frame
At baseline and 24 hours after the first treatment
Title
changes in the Novel P300
Description
measured by electroencephalogram (EEG)
Time Frame
At baseline and 24 hours after the first treatment

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Sheng, 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

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Magnetic Seizure Therapy for Bipolar Mania

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