An interventional study of Repetitive Transcranial Magnetic Stimulation in Schizophrenia, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
The aim of this study is to look at the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary outcome is improvement in negative symptoms related to schizophrenia. The investigators are focusing on negative symptoms given their greater resistance to pharmacological and other established therapies. If the investigators trial were to show beneficial effects, its clinical significance would be great.
This study builds on the results of a previous phase 1, single-site study in which we demonstrated the safety of image-guided theta burst stimulation (TBS) form of rTMS over the cerebellar vermis (Demirtas-Tatlidede et al., 2010) in eigh patients with schizophrenia.
The primary goal of the present study is to assess efficacy of iTBS to the cerebellar vermis on positive and negative symptoms of schizophrenia. A second, added goal is to investigate the mechanisms of the expected clinical improvement.
Schizophrenia is a leading cause of mental disability and current treatments still remain only partially successful for many patients. Our underlying hypothesis is that modulation of the cerebellar vermis may enhance activity of the neural systems that sub-serve cognition and emotion, reestablish the disturbed cerebellar regulation in schizophrenic patients, and produce clinical improvement.
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High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Device: Repetitive Transcranial Magnetic Stimulation
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Device: 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.
Also known as: Transcranial Magnetic Stimulation, Noninvasive Brain Stimulation
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale
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.
Time frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale
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.
Time frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale
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.
Time frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness
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.
Time frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Clinical Global Impression (CGI) Global Improvement
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.
Time frame: Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
Change From Baseline on the Calgary Depression Scale for Schizophrenia
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.
Time frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment
| Milestone | Active rTMS | Sham rTMS |
|---|---|---|
| Started | 10 | 7 |
| Last day of treatment (after 5 days) | 10 | 7 |
| 1 week post treatment | 10 | 6 |
| Completed | 8 | 5 |
| Not completed | 2 | 2 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| 5 days of treatment - baseline | -2.4 ± 3.565 | -1.857 ± 1.574 |
| 1 week post treatment - baseline | -5.889 ± 3.333 | -3.667 ± 3.724 |
| 3 week post treatment - baseline | -5 ± 4.504 | -3 ± 3.317 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| 5 days of treatment - baseline | -1 ± 4.876 | -1.571 ± 2.070 |
| 1 week post treatment - baseline | -3.889 ± 3.296 | -1.667 ± 3.141 |
| 3 week post treatment - baseline | -3.5 ± 6.024 | -0.2 ± 4.604 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| 5 days of treatment - baseline | -3.1 ± 4.149 | -2.714 ± 5.090 |
| 1 week post treatment - baseline | -8.222 ± 5.696 | -2 ± 4.690 |
| 3 week post treatment - baseline | -7.375 ± 10.127 | 0 ± 1 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| 5 days of treatment - baseline | -0.3 ± 0.483 | -0.286 ± 0.488 |
| 1 week post treatment - baseline | -0.4 ± 0.699 | -0.5 ± 0.548 |
| 3 week post treatment - baseline | -0.5 ± 0.535 | -0.2 ± 0.837 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| 5 days of treatment | 3.6 ± 0.516 | 3.429 ± 1.134 |
| 1 week post treatment | 3.3 ± 0.675 | 4 ± 0.632 |
| 3 week post treatment | 3.375 ± 0.518 | 3.8 ± 0.447 |
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.
| units on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| 5 days of treatment - baseline | -2.6 ± 3.204 | -1.167 ± 2.563 |
| 1 week post treatment - baseline | -2.7 ± 2.908 | -1.833 ± 2.229 |
| 3 week post treatment - baseline | -2.25 ± 2.121 | 0.8 ± 2.387 |
Collected over 4 weeks (5 days of treatment and 1 week and 3 weeks post treatment). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active rTMS | — | 1/10 (10%) | 5/10 (50%) |
| Sham rTMS | — | 0/7 (0%) | 1/7 (14.3%) |
| Event | Active rTMS | Sham rTMS |
|---|---|---|
| Acute exacerbation of psychosisPsychiatric disorders | 1/10 | 0/7 |
| Event | Active rTMS | Sham rTMS |
|---|---|---|
| Neck painMusculoskeletal and connective tissue disorders | 3/10 | 1/7 |
| HeadacheNervous system disorders | 2/10 | 1/7 |
| Scalp painSkin and subcutaneous tissue disorders | 0/10 | 1/7 |
| Discomfort with TMSNervous system disorders | 1/10 | 0/7 |
| Blood pressure increaseCardiac disorders | 1/10 | 0/7 |
| Head heavinessMusculoskeletal and connective tissue disorders | 1/10 | 0/7 |
| Change in energy levelNervous system disorders | 1/10 | 0/7 |
| Change in moodPsychiatric disorders | 1/10 | 0/7 |
| Age, Categorical(Participants) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 7 | 17 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 8 | 5 | 13 |
| Region of Enrollment(participants) | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| United States | 10 | 7 | 17 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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