Trial Outcomes & Findings for Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia (NCT NCT01551979)
NCT ID: NCT01551979
Last Updated: 2018-04-12
Results Overview
Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
COMPLETED
NA
22 participants
Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
2018-04-12
Participant Flow
22 patients gave informed consent for the study during the initial screening visit. After patients were found ineligible to participate following review of medical records, withdrew consent, or were lost to follow-up, only 17 remained for the randomization phase and started the study.
Participant milestones
| Measure |
Active rTMS
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
Last Day of Treatment (After 5 Days)
|
10
|
7
|
|
Overall Study
1 Week Post Treatment
|
10
|
6
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
Baseline characteristics by cohort
| Measure |
Active rTMS
n=10 Participants
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 Participants
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
7 participants
n=4 Participants
|
17 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatmentPopulation: Participant drop out
Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Outcome measures
| Measure |
Active rTMS
n=10 Participants
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 Participants
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale
5 days of treatment - baseline
|
-2.4 units on a scale
Standard Deviation 3.565
|
-1.857 units on a scale
Standard Deviation 1.574
|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale
1 week post treatment - baseline
|
-5.889 units on a scale
Standard Deviation 3.333
|
-3.667 units on a scale
Standard Deviation 3.724
|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale
3 week post treatment - baseline
|
-5 units on a scale
Standard Deviation 4.504
|
-3 units on a scale
Standard Deviation 3.317
|
PRIMARY outcome
Timeframe: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatmentPopulation: Participant drop out
Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Outcome measures
| Measure |
Active rTMS
n=10 Participants
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 Participants
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale
5 days of treatment - baseline
|
-1 units on a scale
Standard Deviation 4.876
|
-1.571 units on a scale
Standard Deviation 2.070
|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale
1 week post treatment - baseline
|
-3.889 units on a scale
Standard Deviation 3.296
|
-1.667 units on a scale
Standard Deviation 3.141
|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale
3 week post treatment - baseline
|
-3.5 units on a scale
Standard Deviation 6.024
|
-0.2 units on a scale
Standard Deviation 4.604
|
PRIMARY outcome
Timeframe: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatmentPopulation: Participant drop out
Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Outcome measures
| Measure |
Active rTMS
n=10 Participants
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 Participants
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale
5 days of treatment - baseline
|
-3.1 units on a scale
Standard Deviation 4.149
|
-2.714 units on a scale
Standard Deviation 5.090
|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale
1 week post treatment - baseline
|
-8.222 units on a scale
Standard Deviation 5.696
|
-2 units on a scale
Standard Deviation 4.690
|
|
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale
3 week post treatment - baseline
|
-7.375 units on a scale
Standard Deviation 10.127
|
0 units on a scale
Standard Deviation 1
|
PRIMARY outcome
Timeframe: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatmentPopulation: Participant drop out
Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient's illness at the time of assessment. Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients. Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Outcome measures
| Measure |
Active rTMS
n=10 Participants
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 Participants
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness
5 days of treatment - baseline
|
-0.3 units on a scale
Standard Deviation 0.483
|
-0.286 units on a scale
Standard Deviation 0.488
|
|
Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness
1 week post treatment - baseline
|
-0.4 units on a scale
Standard Deviation 0.699
|
-0.5 units on a scale
Standard Deviation 0.548
|
|
Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness
3 week post treatment - baseline
|
-0.5 units on a scale
Standard Deviation 0.535
|
-0.2 units on a scale
Standard Deviation 0.837
|
PRIMARY outcome
Timeframe: Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatmentPopulation: Participant drop out
Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient's illness has changed compared to baseline. Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Outcome measures
| Measure |
Active rTMS
n=10 Participants
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 Participants
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Clinical Global Impression (CGI) Global Improvement
5 days of treatment
|
3.6 units on a scale
Standard Deviation 0.516
|
3.429 units on a scale
Standard Deviation 1.134
|
|
Clinical Global Impression (CGI) Global Improvement
1 week post treatment
|
3.3 units on a scale
Standard Deviation 0.675
|
4 units on a scale
Standard Deviation 0.632
|
|
Clinical Global Impression (CGI) Global Improvement
3 week post treatment
|
3.375 units on a scale
Standard Deviation 0.518
|
3.8 units on a scale
Standard Deviation 0.447
|
SECONDARY outcome
Timeframe: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatmentPopulation: Participant drop out
The Calgary Depression Scale for Schizophrenia is a 9-item scale that assesses depressive symptoms in patients with schizophrenia. Each item is rated separately and ratings range from 0 to 3. Higher values represent more severe depressive symptoms: 0 indicates an absent symptom and 3 indicates a severe symptom. The overall Calgary Depression Scale score is computed by summing each item. The total Calgary Depression Scale score ranges from 0 to 27, with higher values representing more severe depression in patients with schizophrenia. Change from baseline on the Calgary Depression Scale can range from -27 to +27, with negative values representing an improvement in depressive symptoms and positive values representing worsening depressive symptom severity. Depression was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.
Outcome measures
| Measure |
Active rTMS
n=10 Participants
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 Participants
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Change From Baseline on the Calgary Depression Scale for Schizophrenia
5 days of treatment - baseline
|
-2.6 units on a scale
Standard Deviation 3.204
|
-1.167 units on a scale
Standard Deviation 2.563
|
|
Change From Baseline on the Calgary Depression Scale for Schizophrenia
1 week post treatment - baseline
|
-2.7 units on a scale
Standard Deviation 2.908
|
-1.833 units on a scale
Standard Deviation 2.229
|
|
Change From Baseline on the Calgary Depression Scale for Schizophrenia
3 week post treatment - baseline
|
-2.25 units on a scale
Standard Deviation 2.121
|
0.8 units on a scale
Standard Deviation 2.387
|
Adverse Events
Active rTMS
Sham rTMS
Serious adverse events
| Measure |
Active rTMS
n=10 participants at risk
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 participants at risk
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Psychiatric disorders
Acute exacerbation of psychosis
|
10.0%
1/10 • Number of events 1 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
0.00%
0/7 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
Other adverse events
| Measure |
Active rTMS
n=10 participants at risk
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
Sham rTMS
n=7 participants at risk
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
|
|---|---|---|
|
Nervous system disorders
Discomfort with TMS
|
10.0%
1/10 • Number of events 1 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
0.00%
0/7 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
|
Cardiac disorders
Blood pressure increase
|
10.0%
1/10 • Number of events 1 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
0.00%
0/7 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
14.3%
1/7 • Number of events 2 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/10 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
14.3%
1/7 • Number of events 2 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
30.0%
3/10 • Number of events 4 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
14.3%
1/7 • Number of events 1 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
|
Musculoskeletal and connective tissue disorders
Head heaviness
|
10.0%
1/10 • Number of events 3 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
0.00%
0/7 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
|
Nervous system disorders
Change in energy level
|
10.0%
1/10 • Number of events 2 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
0.00%
0/7 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
|
Psychiatric disorders
Change in mood
|
10.0%
1/10 • Number of events 1 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
0.00%
0/7 • 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment)
0 total number of participants at risk for all-cause mortality because all-cause mortality was not collected/assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place