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

Depression Clinical Trial

Official title:

Bilateral Bispectral Index Monitoring During and After Electroconvulsive Therapy Compared With Magnetic Seizure Therapy for Treatment-resistant Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318018
• Other study ID #: KTB
• Status: Completed
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2017
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• depression

Exclusion Criteria:

• age < 18 years old

• pregnancy

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Seizures

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine & Dept. of Psychiatry and Psychotherapy, University of Bonn Hospital	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery Time	recovery time from seizure induction to eye opening / restoration of breathing	same day

External Links

•   Link to publication