NCT03160664

Magnetic Seizure Therapy for Bipolar Mania

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder, Manic

Interventions

Type	Name	Description
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.
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	treatment as usual (TAU)	Participants will engage in their inpatient treatment program as-usual.

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-03-03
• Completion: 2021-04-26
• First posted: 2017-05-19
• Last updated: 2023-10-31

Locations

1 site across 1 country: China