Magnetic Seizure Therapy for Bipolar Mania

Bipolar Disorder, Manic Clinical Trial

Official title:

Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160664
• Other study ID #: 17411969900
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: April 26, 2021

Study information

• Verified date: September 2021
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 26, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder, Manic
• Seizures

Intervention

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.
• ThymatronSystem ? 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:
• treatment as usual (TAU)
Participants will engage in their inpatient treatment program as-usual.

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 in the Young Mania Rating Scale		At baseline, 4-week follow-up
Secondary	changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)		At baseline and 4-week follow-up
Secondary	changes in the Montgomery Åsberg Depression Rating Scale (MADRS)		At baseline and 4-week follow-up
Secondary	changes in the Clinical Global Impression Scale (CGI)		At baseline and 4-week follow-up
Secondary	changes in the motor threshold (MT)	using single-pulse Transcranial Magnetic Stimulation (sTMS)	At baseline and 24 hours after the first treatment
Secondary	changes in brain gamma-aminobutyric acid (GABA)levels	measured by Magnetic Resonance Spectroscopy (MRS)	At baseline, 24 hours after the first treatment, and at 4-week follow-up
Secondary	changes in the resting state network	measured by Magnetic Resonance Imaging (MRI)	At baseline, 24 hours after the first treatment, and at 4-week follow-up
Secondary	changes in auditory evoked potentials (AEP)	measured by electroencephalogram (EEG)	At baseline and 24 hours after the first treatment
Secondary	changes in the Novel P300	measured by electroencephalogram (EEG)	At baseline and 24 hours after the first treatment