Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania

Bipolar Disorder, Manic Clinical Trial

Official title:

Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03016104
• Other study ID #: SHDC12014111b
• Status: Withdrawn
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2022
• 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• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• 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 positive and negative syndrome scale (PANSS) score = 60;

4. informed consent in written form.

Exclusion Criteria:

1. 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. 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 Positive and Negative Syndrome Scale (PANSS)		At baseline, 4-week follow-up, and 8-week follow-up
Secondary	changes in MATRICS Consensus Cognitive Battery (MCCB)		At baseline and 4-week follow-up
Secondary	changes in Clinical Global Impressions (CGI)		At baseline and 4-week follow-up
Secondary	changes in motor threshold (MT)	using single-pulse Transcranial Magnetic Stimulation (sTMS)	At baseline and the day after the first treatment
Secondary	changes in brain gamma-aminobutyric acid (GABA)levels	measured by Magnetic Resonance Spectroscopy (MRS)	At baseline, the day after the first treatment, and at 4-week follow-up
Secondary	changes in resting state network	measured by Magnetic Resonance Imaging (MRI)	At baseline, the day after the first treatment, and at 4-week follow-up
Secondary	changes in auditory evoked potential (AEP)	measured by electroencephalogram (EEG)	At baseline and the day after the first treatment
Secondary	changes in Novel P300	measured by electroencephalogram (EEG)	At baseline and the day after the first treatment