Investigation on the Value of Bilateral Index (BIS) Monitoring for Magnetic Seizure Versus Electroconvulsive Therapy

NCT ID: NCT01318018

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-02-29

Brief Summary

Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients suffering from depression, who do not respond to medical treatment. However it is often dismissed by patients, who feel uncomfortably about the application of electric shocks to their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of its antidepressant potency but may be associated with less severe cognitive side effects.

Control of anaesthesia during seizure therapy is demanding since light anesthesia might be associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor anaesthesia for ECT, however little is known about BIS following MST.

The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster increase in BIS and that (b)less left-right differences occur in BIS.

Conditions

Depression

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Magnetic Seizure Therapy Group

Patients receiving magnetic seizure therapy for depression

No interventions assigned to this group

Electroconvulsive Therapy Group

Patients receiving electroconvulsive therapy for depression

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• depression

Exclusion Criteria

• age < 18 years old
• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Martin Soehle

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Soehle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Anaesthesiology and Intensive Care Medicine

Locations

Dept. of Anaesthesiology and Intensive Care Medicine & Dept. of Psychiatry and Psychotherapy, University of Bonn Hospital

Bonn, , Germany

Countries

Germany

References

Soehle M, Kayser S, Ellerkmann RK, Schlaepfer TE. Bilateral bispectral index monitoring during and after electroconvulsive therapy compared with magnetic seizure therapy for treatment-resistant depression. Br J Anaesth. 2014 Apr;112(4):695-702. doi: 10.1093/bja/aet410. Epub 2013 Dec 3.

Reference Type: RESULT

PMID: 24305645 (View on PubMed)

Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.

Reference Type: DERIVED

PMID: 34131914 (View on PubMed)

Other Identifiers

KTB

Identifier Type: -

Identifier Source: org_study_id