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| Name | Class |
|---|---|
| Sidney R. Baer, Jr. Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Active Comparator | High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum. |
|
| Sham rTMS | Sham Comparator | Sham rTMS to the vermis (lobule VII) of the cerebellum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Halko, Ph.D. | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 80249 | Background | Batini C, Buisseret-Delmas C, Corvisier J, Hardy O, Jassik-Gerschenfeld D. Brain stem nuclei giving fibers to lobules VI and VII of the cerebellar vermis. Brain Res. 1978 Sep 22;153(2):241-61. doi: 10.1016/0006-8993(78)90405-5. | |
| 20817483 | Background | Demirtas-Tatlidede A, Freitas C, Cromer JR, Safar L, Ongur D, Stone WS, Seidman LJ, Schmahmann JD, Pascual-Leone A. Safety and proof of principle study of cerebellar vermal theta burst stimulation in refractory schizophrenia. Schizophr Res. 2010 Dec;124(1-3):91-100. doi: 10.1016/j.schres.2010.08.015. |
| Label | URL |
|---|---|
| Related Information | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participant drop out | Posted | Mean | Standard Deviation | units on a scale | Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute exacerbation of psychosis | Psychiatric disorders | Systematic Assessment | Acute exacerbation of psychosis was assessed to be possibly related to participation in the study, but likely not related to the TMS. Subject was hospitalized. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort with TMS | Nervous system disorders | Systematic Assessment | Discomfort with the TMS-EEG measures being done at baseline in the frontal lobe area. Discomfort was assessed to be related to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Halko | Beth Israel Deaconess Medical Center | 6176670367 | mhalko@bidmc.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
|
| 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. | 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. | Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
| Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
| 21132574 | Background | Demirtas-Tatlidede A, Freitas C, Pascual-Leone A, Schmahmann JD. Modulatory effects of theta burst stimulation on cerebellar nonsomatic functions. Cerebellum. 2011 Sep;10(3):495-503. doi: 10.1007/s12311-010-0230-5. |
| 16809569 | Background | Fregni F, Boggio PS, Valle AC, Rocha RR, Duarte J, Ferreira MJ, Wagner T, Fecteau S, Rigonatti SP, Riberto M, Freedman SD, Pascual-Leone A. A sham-controlled trial of a 5-day course of repetitive transcranial magnetic stimulation of the unaffected hemisphere in stroke patients. Stroke. 2006 Aug;37(8):2115-22. doi: 10.1161/01.STR.0000231390.58967.6b. Epub 2006 Jun 29. |
| 15990468 | Background | Fregni F, Thome-Souza S, Bermpohl F, Marcolin MA, Herzog A, Pascual-Leone A, Valente KD. Antiepileptic effects of repetitive transcranial magnetic stimulation in patients with cortical malformations: an EEG and clinical study. Stereotact Funct Neurosurg. 2005;83(2-3):57-62. doi: 10.1159/000086674. Epub 2005 Jun 30. |
| 17239806 | Background | Fregni F, Freedman S, Pascual-Leone A. Recent advances in the treatment of chronic pain with non-invasive brain stimulation techniques. Lancet Neurol. 2007 Feb;6(2):188-91. doi: 10.1016/S1474-4422(07)70032-7. |
| 8547583 | Background | George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008. |
| 11122913 | Background | George MS, Nahas Z, Kozel FA, Goldman J, Molloy M, Oliver N. Improvement of depression following transcranial magnetic stimulation. Curr Psychiatry Rep. 1999 Dec;1(2):114-24. doi: 10.1007/s11920-999-0020-2. |
| 12727683 | Background | Gershon AA, Dannon PN, Grunhaus L. Transcranial magnetic stimulation in the treatment of depression. Am J Psychiatry. 2003 May;160(5):835-45. doi: 10.1176/appi.ajp.160.5.835. |
| 15697042 | Background | Hajak G, Marienhagen J, Langguth B, Werner S, Binder H, Eichhammer P. High-frequency repetitive transcranial magnetic stimulation in schizophrenia: a combined treatment and neuroimaging study. Psychol Med. 2004 Oct;34(7):1157-63. doi: 10.1017/s0033291704002338. |
| 7496779 | Background | Hashimoto M, Ohtsuka K. Transcranial magnetic stimulation over the posterior cerebellum during visually guided saccades in man. Brain. 1995 Oct;118 ( Pt 5):1185-93. doi: 10.1093/brain/118.5.1185. |
| 303280 | Background | Heath RG. Modulation of emotion with a brain pacemamer. Treatment for intractable psychiatric illness. J Nerv Ment Dis. 1977 Nov;165(5):300-17. |
| 728506 | Background | Heath RG, Dempesy CW, Fontana CJ, Myers WA. Cerebellar stimulation: effects on septal region, hippocampus, and amygdala of cats and rats. Biol Psychiatry. 1978 Oct;13(5):501-29. |
| 14500119 | Background | Huber TJ, Schneider U, Rollnik J. Gender differences in the effect of repetitive transcranial magnetic stimulation in schizophrenia. Psychiatry Res. 2003 Aug 30;120(1):103-5. doi: 10.1016/s0165-1781(03)00170-7. |
| 17389898 | Background | Jardri R, Lucas B, Delevoye-Turrell Y, Delmaire C, Delion P, Thomas P, Goeb JL. An 11-year-old boy with drug-resistant schizophrenia treated with temporo-parietal rTMS. Mol Psychiatry. 2007 Apr;12(4):320. doi: 10.1038/sj.mp.4001968. No abstract available. |
| 16254067 | Background | Jin Y, Potkin SG, Kemp AS, Huerta ST, Alva G, Thai TM, Carreon D, Bunney WE Jr. Therapeutic effects of individualized alpha frequency transcranial magnetic stimulation (alphaTMS) on the negative symptoms of schizophrenia. Schizophr Bull. 2006 Jul;32(3):556-61. doi: 10.1093/schbul/sbj020. Epub 2005 Oct 27. |
| 15118944 | Background | Martin PI, Naeser MA, Theoret H, Tormos JM, Nicholas M, Kurland J, Fregni F, Seekins H, Doron K, Pascual-Leone A. Transcranial magnetic stimulation as a complementary treatment for aphasia. Semin Speech Lang. 2004 May;25(2):181-91. doi: 10.1055/s-2004-825654. |
| 9549519 | Background | Ohtsuka K, Enoki T. Transcranial magnetic stimulation over the posterior cerebellum during smooth pursuit eye movements in man. Brain. 1998 Mar;121 ( Pt 3):429-35. doi: 10.1093/brain/121.3.429. |
| 7711480 | Background | Papez JW. A proposed mechanism of emotion. 1937. J Neuropsychiatry Clin Neurosci. 1995 Winter;7(1):103-12. doi: 10.1176/jnp.7.1.103. No abstract available. |
| 8684201 | Background | Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6. |
| 11192620 | Background | Rollnik JD, Huber TJ, Mogk H, Siggelkow S, Kropp S, Dengler R, Emrich HM, Schneider U. High frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex in schizophrenic patients. Neuroreport. 2000 Dec 18;11(18):4013-5. doi: 10.1097/00001756-200012180-00022. |
| 19833552 | Background | Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. |
| 20821056 | Background | Schmahmann JD. The role of the cerebellum in cognition and emotion: personal reflections since 1982 on the dysmetria of thought hypothesis, and its historical evolution from theory to therapy. Neuropsychol Rev. 2010 Sep;20(3):236-60. doi: 10.1007/s11065-010-9142-x. Epub 2010 Sep 7. |
| 12499043 | Background | Schutter DJ, van Honk J, d'Alfonso AA, Peper JS, Panksepp J. High frequency repetitive transcranial magnetic over the medial cerebellum induces a shift in the prefrontal electroencephalography gamma spectrum: a pilot study in humans. Neurosci Lett. 2003 Jan 16;336(2):73-6. doi: 10.1016/s0304-3940(02)01077-7. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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.
| OG001 | 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. |
|
|
| Primary | 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. | Participant drop out | Posted | Mean | Standard Deviation | units on a scale | Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
|
|
|
| Primary | 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. | Participant drop out | Posted | Mean | Standard Deviation | units on a scale | Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
|
|
|
| Primary | 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. | Participant drop out | Posted | Mean | Standard Deviation | units on a scale | Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
|
|
|
| Primary | 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. | Participant drop out | Posted | Mean | Standard Deviation | units on a scale | Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
|
|
|
| Secondary | 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. | Participant drop out | Posted | Mean | Standard Deviation | units on a scale | Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment |
|
|
|
| 0 |
| 0 |
| 1 |
| 10 |
| 5 |
| 10 |
| EG001 | 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. | 0 | 0 | 0 | 7 | 1 | 7 |
|
|
| Blood pressure increase | Cardiac disorders | Systematic Assessment | Blood pressure elevation was assessed to be possibly related to the study. |
|
| Headache | Nervous system disorders | Systematic Assessment | Headaches were reported during EEG measures during baseline assessment, pre-TMS, and post-TMS. Headaches were assessed as possibly or probably related to the study. |
|
| Scalp pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Scalp pain reported as pressure on scalp over the ears and top of head. Scalp pain was assessed as possibly related to the study. |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Neck pain reported due to dystonia or heaviness of the coil. Neck pain due to dystonia was assessed as not related to study participation. Neck pain due to the coil was assessed as probably related to the study. |
|
| Head heaviness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Heaviness was reported on right side of head during and after TMS. Headache was assessed to be possibly related to the study. |
|
| Change in energy level | Nervous system disorders | Systematic Assessment | Subject reported being mildly or moderately tired post-TMS. |
|
| Change in mood | Psychiatric disorders | Systematic Assessment | Subject reported feeling depressed. Change in mood assessed to be possibly related to the study. |
|
Not provided
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| 1 week post treatment - baseline |
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| 3 week post treatment - baseline |
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| 1 week post treatment - baseline |
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| 3 week post treatment - baseline |
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| 1 week post treatment - baseline |
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| 3 week post treatment - baseline |
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| 1 week post treatment |
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| 3 week post treatment |
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| 1 week post treatment - baseline |
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| 3 week post treatment - baseline |
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