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Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania

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ClinicalTrials.gov Identifier: NCT03016104
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Bipolar Disorder, Manic Device: Magpro X100 + Option Device: ThymatronSystem Ⅳ Electroconvulsive System Other: treatment as usual (TAU)

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania
Study Start Date : November 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: magnetic seizure therapy
10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.
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.
Other Name: magnetic seizure therapy
Other: treatment as usual (TAU)
Participants will engage in their inpatient treatment program as-usual.
Active Comparator: electroconvulsive therapy
10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per 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 Name: electroconvulsive therapy
Other: treatment as usual (TAU)
Participants will engage in their inpatient treatment program as-usual.


Outcome Measures

Primary Outcome Measures :
  1. changes in The Positive and Negative Syndrome Scale (PANSS) [ Time Frame: At baseline, 4-week follow-up, and 8-week follow-up ]

Secondary Outcome Measures :
  1. changes in MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: At baseline and 4-week follow-up ]
  2. changes in Clinical Global Impressions (CGI) [ Time Frame: At baseline and 4-week follow-up ]
  3. changes in motor threshold (MT) [ Time Frame: At baseline and the day after the first treatment ]
    using single-pulse Transcranial Magnetic Stimulation (sTMS)

  4. changes in brain gamma-aminobutyric acid (GABA)levels [ Time Frame: At baseline, the day after the first treatment, and at 4-week follow-up ]
    measured by Magnetic Resonance Spectroscopy (MRS)

  5. changes in resting state network [ Time Frame: At baseline, the day after the first treatment, and at 4-week follow-up ]
    measured by Magnetic Resonance Imaging (MRI)

  6. changes in auditory evoked potential (AEP) [ Time Frame: At baseline and the day after the first treatment ]
    measured by electroencephalogram (EEG)

  7. changes in Novel P300 [ Time Frame: At baseline and the day after the first treatment ]
    measured by electroencephalogram (EEG)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016104


Contacts
Contact: Chunbo Li, PHD 86-21-34773243 chunbo_li@163.com
Contact: Jijun Wang, PHD 86-21-34773065 jijunwang27@163.com

Locations
China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Chunbo Li, PHD    86-21-34773243    chunbo_li@163.com   
Principal Investigator: Chunbo Li, PHD         
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Principal Investigator: Chunbo Li, PHD Shanghai Mental Health Center
More Information

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03016104     History of Changes
Other Study ID Numbers: SHDC12014111b
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shanghai Mental Health Center:
magnetic seizure therapy
electroconvulsive therapy
bipolar mania
cognition
controlled trial

Additional relevant MeSH terms:
Bipolar Disorder
Seizures
Bipolar and Related Disorders
Mental Disorders
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms