Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01318018
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2011-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigation on the Value of Bilateral Index (BIS) Monitoring for Magnetic Seizure Versus Electroconvulsive Therapy
Sponsor:
University Hospital, Bonn
Organization:
Study Overview
Official Title:
Bilateral Bispectral Index Monitoring During and After Electroconvulsive Therapy Compared With Magnetic Seizure Therapy for Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: