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Trial record 2 of 11 for:    Recruiting, Not yet recruiting, Available Studies | Mania

Magnetic Seizure Therapy for Bipolar Mania

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ClinicalTrials.gov Identifier: NCT03160664
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

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 Phase
Bipolar Disorder, Manic Device: Magpro X100 + Option Device: ThymatronSystem Ⅳ Electroconvulsive System Other: treatment as usual (TAU) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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.




Primary Outcome Measures :
  1. changes in the Young Mania Rating Scale [ Time Frame: At baseline, 4-week follow-up, and 8-week follow-up ]

Secondary Outcome Measures :
  1. changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS) [ Time Frame: At baseline and 4-week follow-up ]
  2. changes in the Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: At baseline and 4-week follow-up ]
  3. changes in the Clinical Global Impression Scale (CGI) [ Time Frame: At baseline and 4-week follow-up ]
  4. changes in the motor threshold (MT) [ Time Frame: At baseline and 24 hours after the first treatment ]
    using single-pulse Transcranial Magnetic Stimulation (sTMS)

  5. changes in brain gamma-aminobutyric acid (GABA)levels [ Time Frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up ]
    measured by Magnetic Resonance Spectroscopy (MRS)

  6. changes in the resting state network [ Time Frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up ]
    measured by Magnetic Resonance Imaging (MRI)

  7. changes in auditory evoked potentials (AEP) [ Time Frame: At baseline and 24 hours after the first treatment ]
    measured by electroencephalogram (EEG)

  8. changes in the Novel P300 [ Time Frame: At baseline and 24 hours after the first treatment ]
    measured by electroencephalogram (EEG)



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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 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.

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): NCT03160664


Contacts
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Contact: Jianhua Sheng, PHD 86-21-34773759 shengjianhua66@163.com
Contact: Chunbo Li, PHD 86-21-34773243 chunbo_li@163.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jianhua Sheng, PHD         
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Principal Investigator: Jianhua Sheng, PHD Shanghai Mental Health Center

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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03160664     History of Changes
Other Study ID Numbers: 17411969900
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
magnetic seizure therapy
electroconvulsive therapy
bipolar mania
cognition
randomized controlled trial
Additional relevant MeSH terms:
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Seizures
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms