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

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ClinicalTrials.gov Identifier: NCT01318018
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Martin Soehle, University Hospital, Bonn

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
Depression

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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 : February 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort
Magnetic Seizure Therapy Group
Patients receiving magnetic seizure therapy for depression
Electroconvulsive Therapy Group
Patients receiving electroconvulsive therapy for depression



Primary Outcome Measures :
  1. Recovery Time [ Time Frame: same day ]
    recovery time from seizure induction to eye opening / restoration of breathing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from depression
Criteria

Inclusion Criteria:

  • depression

Exclusion Criteria:

  • age < 18 years old
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318018


Locations
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Germany
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
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Principal Investigator: Martin Soehle, MD, PhD Dept of Anaesthesiology and Intensive Care Medicine
Additional Information:
Publications of Results:
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Responsible Party: Martin Soehle, Consultant, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01318018    
Other Study ID Numbers: KTB
First Posted: March 18, 2011    Key Record Dates
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Martin Soehle, University Hospital, Bonn:
depression
bispectral index
electroconvulsive therapy
magnetic seizure therapy
Additional relevant MeSH terms:
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Seizures
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases