Trial Outcomes & Findings for Investigation on the Value of Bilateral Index (BIS) Monitoring for Magnetic Seizure Versus Electroconvulsive Therapy (NCT NCT01318018)
NCT ID: NCT01318018
Last Updated: 2018-10-05
Results Overview
recovery time from seizure induction to eye opening / restoration of breathing
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
same day
Results posted on
2018-10-05
Participant Flow
Participant milestones
| Measure |
Magnetic Seizure Therapy Group
Patients receiving magnetic seizure therapy for depression completed
|
Electroconvulsive Therapy Group
Patients receiving electroconvulsive therapy for depression
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation on the Value of Bilateral Index (BIS) Monitoring for Magnetic Seizure Versus Electroconvulsive Therapy
Baseline characteristics by cohort
| Measure |
Magnetic Seizure Therapy Group
n=10 Participants
Patients receiving magnetic seizure therapy for depression
|
Electroconvulsive Therapy Group
n=10 Participants
Patients receiving electroconvulsive therapy for depression
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 14 • n=5 Participants
|
55 years
STANDARD_DEVIATION 12 • n=7 Participants
|
50 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: same dayrecovery time from seizure induction to eye opening / restoration of breathing
Outcome measures
| Measure |
Magnetic Seizure Therapy Group
n=10 Participants
Patients receiving magnetic seizure therapy for depression recovery time
|
Electroconvulsive Therapy Group
n=10 Participants
Patients receiving electroconvulsive therapy for depression recovery time
|
|---|---|---|
|
Recovery Time
|
3.0 minutes
Standard Deviation 1.0
|
6.7 minutes
Standard Deviation 1.3
|
Adverse Events
Magnetic Seizure Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Electroconvulsive Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr.Martin Soehle
Dept. of Anesthesiology and Intensive Care Medicine
Phone: ++49-228-287-
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place