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

• Sponsor: University Hospital, Bonn (Other)
• Overall Status: Completed
• CT.gov ID: NCT01318018
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Bilateral Bispectral Index Monitoring During and After Electroconvulsive Therapy Compared With Magnetic Seizure Therapy for Treatment-resistant Depression
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Magnetic Seizure Therapy Group Patients receiving magnetic seizure therapy for depression
Electroconvulsive Therapy Group Patients receiving electroconvulsive therapy for depression

Outcome Measures

Primary Outcome Measures

1. Recovery Time [same day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• depression

Exclusion Criteria:

• age < 18 years old

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Anaesthesiology and Intensive Care Medicine & Dept. of Psychiatry and Psychotherapy, University of Bonn Hospital	Bonn		Germany

Sponsors and Collaborators

• University Hospital, Bonn

Investigators

• Principal Investigator: Martin Soehle, MD, PhD, Dept of Anaesthesiology and Intensive Care Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to publication

Publications

None provided.

• Responsible Party: Martin Soehle, Consultant, University Hospital, Bonn
• ClinicalTrials.gov Identifier: NCT01318018
• Other Study ID Numbers: KTB
• First Posted: Mar 18, 2011
• Last Update Posted: Oct 5, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Martin Soehle, Consultant, University Hospital, Bonn: depression; bispectral index; electroconvulsive therapy; magnetic seizure therapy
• Additional relevant MeSH terms: Seizures; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Magnetic Seizure Therapy Group	Electroconvulsive Therapy Group
Arm/Group Description	Patients receiving magnetic seizure therapy for depression completed	Patients receiving electroconvulsive therapy for depression
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Magnetic Seizure Therapy Group	Electroconvulsive Therapy Group	Total
Arm/Group Description	Patients receiving magnetic seizure therapy for depression	Patients receiving electroconvulsive therapy for depression	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (14)	55 (12)	50 (14)
Sex: Female, Male (Count of Participants)
Female	3 30%	4 40%	7 35%
Male	7 70%	6 60%	13 65%
Region of Enrollment (participants) [Number]
Germany	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Recovery Time
Description	recovery time from seizure induction to eye opening / restoration of breathing
Time Frame	same day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magnetic Seizure Therapy Group	Electroconvulsive Therapy Group
Arm/Group Description	Patients receiving magnetic seizure therapy for depression recovery time	Patients receiving electroconvulsive therapy for depression recovery time
Measure Participants	10	10
Mean (Standard Deviation) [minutes]	3.0 (1.0)	6.7 (1.3)

Adverse Events

Arm/Group Title	Magnetic Seizure Therapy Group		Electroconvulsive Therapy Group
Arm/Group Description	Patients receiving magnetic seizure therapy for depression: None		Patients receiving electroconvulsive therapy for depression: None
All Cause Mortality
	Magnetic Seizure Therapy Group		Electroconvulsive Therapy Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Magnetic Seizure Therapy Group		Electroconvulsive Therapy Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Magnetic Seizure Therapy Group		Electroconvulsive Therapy Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.