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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01318018
Enrollment
20
Registered
2011-03-18
Start date
2011-02-28
Completion date
2012-02-29
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, bispectral index, electroconvulsive therapy, magnetic seizure therapy

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.

Interventions

None listed

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* depression

Exclusion criteria

* age \< 18 years old * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Recovery Timesame dayrecovery time from seizure induction to eye opening / restoration of breathing

Countries

Germany

Participant flow

Participants by arm

ArmCount
Magnetic Seizure Therapy Group
Patients receiving magnetic seizure therapy for depression
10
Electroconvulsive Therapy Group
Patients receiving electroconvulsive therapy for depression
10
Total20

Baseline characteristics

CharacteristicMagnetic Seizure Therapy GroupElectroconvulsive Therapy GroupTotal
Age, Continuous45 years
STANDARD_DEVIATION 14
55 years
STANDARD_DEVIATION 12
50 years
STANDARD_DEVIATION 14
Region of Enrollment
Germany
10 participants10 participants20 participants
Sex: Female, Male
Female
3 Participants4 Participants7 Participants
Sex: Female, Male
Male
7 Participants6 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 10

Outcome results

Primary

Recovery Time

recovery time from seizure induction to eye opening / restoration of breathing

Time frame: same day

ArmMeasureValue (MEAN)Dispersion
Magnetic Seizure Therapy GroupRecovery Time3.0 minutesStandard Deviation 1
Electroconvulsive Therapy GroupRecovery Time6.7 minutesStandard Deviation 1.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026