Trial Outcomes & Findings for Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (NCT NCT03191058)
NCT ID: NCT03191058
Last Updated: 2026-05-11
Results Overview
This scale is used to quantify the severity of symptoms of depression * Scale range: 0-76 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Remission defined as a HRSD-24 total score of ≤10 and 60% reduction from baseline on two consecutive assessments. The outcome is reported as number of participants meeting remission criteria in each treatment group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
239 participants
Primary outcome timeframe
Approximately 7 weeks
Results posted on
2026-05-11
Participant Flow
Out of 119 allocated to MST arm, 2 Did not receive allocated intervention. Out of 120 allocated to ECT arm, 1 Did not receive allocated intervention.
Participant milestones
| Measure |
Magnetic Seizure Therapy (MST)
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
120
|
|
Overall Study
COMPLETED
|
111
|
108
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression
Baseline characteristics by cohort
| Measure |
Magnetic Seizure Therapy (MST)
n=117 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=119 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=44 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
100 Participants
n=44 Participants
|
95 Participants
n=10 Participants
|
195 Participants
n=30 Participants
|
|
Age, Continuous
|
44.5 Years
STANDARD_DEVIATION 13.8 • n=44 Participants
|
45.5 Years
STANDARD_DEVIATION 14.8 • n=10 Participants
|
45 Years
STANDARD_DEVIATION 14.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=44 Participants
|
65 Participants
n=10 Participants
|
135 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=44 Participants
|
54 Participants
n=10 Participants
|
101 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
12 Participants
n=44 Participants
|
7 Participants
n=10 Participants
|
19 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
1 Participants
n=44 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=44 Participants
|
7 Participants
n=10 Participants
|
8 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
1 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Approximately 7 weeksPopulation: In the MST arm, 2 did not receive allocated intervention, and in the ECT arm, 1 did not receive allocated intervention, and therefore they were not included in the analysis. In the ECT arm, 11 participants were discontinued before adequate trial or remission, and in the MST arm 6 participants were discontinued before adequate trial or remission - these participants were not included in the primary non-inferiority analysis.
This scale is used to quantify the severity of symptoms of depression * Scale range: 0-76 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Remission defined as a HRSD-24 total score of ≤10 and 60% reduction from baseline on two consecutive assessments. The outcome is reported as number of participants meeting remission criteria in each treatment group.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=111 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=108 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Remission of Depression on the Hamilton Rating Scale for Depression-24 Item (HRSD-24)
|
25 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: Approximately 7 weeksPopulation: In the MST arm, 2 did not receive allocated intervention, and in the ECT arm, 1 did not receive allocated intervention, and therefore they were not included in the analysis. In the ECT arm, 11 participants were discontinued before adequate trial or remission, and in the MST arm 6 participants were discontinued begore adequate trial or remission - these participants were not included in the primary non-inferiority analysis.
In the Autobiographical Memory Test (AMT), participants are presented with emotional cue words and asked to retrieve a personal memory within a brief response window; interview formats have been shown to produce fewer specific and more overgeneral memories. The outcome is reported as the number of participants who meet the predefined worsening criterion at follow-up. The binary outcome was defined as a worsening from baseline of \>25% on the AMT total score.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=111 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=108 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Worsening of Autobiographical Memory on the Autobiographical Memory Test (AMT)
|
3 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: SSI data are analyzed including only participants who had a non-zero SSI score at baseline.
Remission of suicidal ideation will be assessed using the Scale for Suicidal Ideation (SSI), a clinician-administered tool with 19 scored items rated 0-2, total score range 0-38. Higher scores indicate greater suicidal ideation severity. Remission is defined as an SSI total score of 0 at follow-up. The outcome is the number of participants who meet remission criteria compared with baseline.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=91 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=75 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Remission on the Scale for Suicidal Ideation (SSI)
|
44 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: Response data are reported from the completer sample (ECT = 108, MST = 111).
This scale is used to quantify the severity of symptoms of depression * Scale range: 0-76 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Response is defined as a HRSD-24 reduction of 50% or greater from baseline The outcome is reported as number of participants meeting response criteria in each treatment group.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=111 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=108 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Response on the Hamilton Rating Scale for Depression-24 Item (HRSD-24)
|
52 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: In the MST arm, 2 did not receive allocated intervention, and in the ECT arm, 1 did not receive allocated intervention, and therefore they were not included in the analysis.
The Brief Symptom Inventory (BSI) anxiety section (ANX) is a subscale comprised of 6 items designed to measure subjective experiences of tension, panic, and restlessness over the past week. It uses a 5-point Likert scale (0=not at all to 4=extremely) to identify symptoms like "nervousness," "feeling tense," or "spells of terror". Higher = worse; lower = better. The total score ranges from 0 to 24.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=117 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=119 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Score on the Brief Symptom Inventory Anxiety Section (BSI-A)
|
5.2 Score on the BSI-A scale
Standard Deviation 5.3
|
6.5 Score on the BSI-A scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: In the MST arm, 2 did not receive allocated intervention, and in the ECT arm, 1 did not receive allocated intervention, and therefore they were not included in the analysis. There were 3 missing post-CGI-I in the MST group and 7 missing post-CGI-I scores in the ECT group.
The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point, observer-rated tool used to measure how much a patient's illness has improved or worsened relative to their baseline. It is rated from 1 (very much improved) to 7 (very much worse). Response is defined as a CGI-I score of 1 or 2.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=114 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=112 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Response on the Clinical Global Impression - Improvement Scale (CGI-I)
Minimally Improved
|
31 Participants
|
26 Participants
|
|
Response on the Clinical Global Impression - Improvement Scale (CGI-I)
No Change
|
24 Participants
|
18 Participants
|
|
Response on the Clinical Global Impression - Improvement Scale (CGI-I)
Minimally Worse
|
9 Participants
|
16 Participants
|
|
Response on the Clinical Global Impression - Improvement Scale (CGI-I)
Much Worse
|
2 Participants
|
2 Participants
|
|
Response on the Clinical Global Impression - Improvement Scale (CGI-I)
Very Much Improved
|
21 Participants
|
13 Participants
|
|
Response on the Clinical Global Impression - Improvement Scale (CGI-I)
Much Improved
|
27 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: In the MST arm, 2 did not receive allocated intervention, and in the ECT arm, 1 did not receive allocated intervention, and therefore they were not included in the analysis.
The Q-LES-Q-SF (Short Form) measures quality of life through 14 items, each rated on a 1-5 scale (1=Very Poor, 5=Very Good). Total raw scores range from 14 to 70, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=117 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=119 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Score on the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
|
41.3 Score on the Q-LES-Q scale
Standard Deviation 11.7
|
42.5 Score on the Q-LES-Q scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Approximately 7 weeksPopulation: In the MST arm, 2 did not receive allocated intervention, and in the ECT arm, 1 did not receive allocated intervention, and therefore they were not included in the analysis.
The Columbia ECT Subjective Side Effects Schedule is a tool used to monitor adverse effects after each ECT session and at baseline. It tracks physical, cognitive, and mood side effects. For the physical scale (range 0-15) and cognitive scale (range 0-6) it uses a 4-point Likert-type scale where 0 = none; 1 = yes, mild; 2 = yes, moderate; and 3 = yes, severe. For the mood scale (range 0-3) it uses a 2-point Likert-type scale where 0 = no; 1 = yes. For the physical and cognitive scales, higher values indicate a worse outcome. For the mood scale, higher values indicate a better outcome.
Outcome measures
| Measure |
Magnetic Seizure Therapy (MST)
n=117 Participants
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=119 Participants
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Score on the Columbia ECT Subjective Side Effects Schedule (CSSES)
Physical Domain
|
0.4 Score on the CSSES scale
Standard Deviation 0.5
|
0.5 Score on the CSSES scale
Standard Deviation 0.5
|
|
Score on the Columbia ECT Subjective Side Effects Schedule (CSSES)
Cognitive Domain
|
0.2 Score on the CSSES scale
Standard Deviation 0.4
|
0.8 Score on the CSSES scale
Standard Deviation 0.8
|
|
Score on the Columbia ECT Subjective Side Effects Schedule (CSSES)
Mood Domain
|
0.6 Score on the CSSES scale
Standard Deviation 0.4
|
0.6 Score on the CSSES scale
Standard Deviation 0.5
|
Adverse Events
Magnetic Seizure Therapy (MST)
Serious events: 8 serious events
Other events: 114 other events
Deaths: 1 deaths
Electroconvulsive Therapy (ECT)
Serious events: 2 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Magnetic Seizure Therapy (MST)
n=117 participants at risk
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=119 participants at risk
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
3.4%
4/117 • Approximately 8 months.
|
0.84%
1/119 • Approximately 8 months.
|
|
Renal and urinary disorders
Hospitalization
|
0.85%
1/117 • Approximately 8 months.
|
0.00%
0/119 • Approximately 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/117 • Approximately 8 months.
|
0.84%
1/119 • Approximately 8 months.
|
|
Gastrointestinal disorders
Hospitalization
|
0.85%
1/117 • Approximately 8 months.
|
0.00%
0/119 • Approximately 8 months.
|
|
Blood and lymphatic system disorders
Hospitalization
|
0.85%
1/117 • Approximately 8 months.
|
0.00%
0/119 • Approximately 8 months.
|
|
Cardiac disorders
Death
|
0.85%
1/117 • Approximately 8 months.
|
0.00%
0/119 • Approximately 8 months.
|
Other adverse events
| Measure |
Magnetic Seizure Therapy (MST)
n=117 participants at risk
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Magnetic Seizure Therapy: MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.
|
Electroconvulsive Therapy (ECT)
n=119 participants at risk
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
Electroconvulsive Therapy: In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
8.5%
10/117 • Approximately 8 months.
|
23.5%
28/119 • Approximately 8 months.
|
|
Nervous system disorders
Headache
|
70.9%
83/117 • Approximately 8 months.
|
84.0%
100/119 • Approximately 8 months.
|
|
Gastrointestinal disorders
Nausea
|
35.9%
42/117 • Approximately 8 months.
|
47.1%
56/119 • Approximately 8 months.
|
|
Psychiatric disorders
Confusion
|
5.1%
6/117 • Approximately 8 months.
|
18.5%
22/119 • Approximately 8 months.
|
|
Psychiatric disorders
Post-ictal agitation
|
0.85%
1/117 • Approximately 8 months.
|
5.0%
6/119 • Approximately 8 months.
|
|
General disorders
Memory impairment
|
26.5%
31/117 • Approximately 8 months.
|
58.0%
69/119 • Approximately 8 months.
|
|
General disorders
Post-treatment breathing difficulty
|
24.8%
29/117 • Approximately 8 months.
|
3.4%
4/119 • Approximately 8 months.
|
|
Musculoskeletal and connective tissue disorders
Aching/stiffness in muscles
|
64.1%
75/117 • Approximately 8 months.
|
66.4%
79/119 • Approximately 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place