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This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients
The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Active Comparator | Active treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC). |
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| Sham rTMS | Sham Comparator | Sham stimulation will be delivered using the same stimulation parameters and at the same site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | Stimulate the dorsomedial prefrontal cortex for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale) | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | |
| Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS] |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Letter-Number Span | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | |
| Change from baseline in Wechsler Working Memory | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dengtang Liu, MD | Contact | +86 21 64387250-73775 | erliu110@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2021 | |
| Reset | Apr 27, 2021 | |
| Release | Aug 11, 2022 | |
| Reset | Jul 3, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2021 | Apr 27, 2021 | |||
| Aug 11, 2022 |
| 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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| 3 times (Before treatment,immediately after treatment,4 weeks after treatment) |
| Change from baseline in clinical global impression [CGI] | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) |
| Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0] | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) |
| Change from baseline in Simpson-Angus Scale [SAS] | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) |
| Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS] | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) |
| Change from baseline in Resting-state functional MRI:TR=2000 ms,TE=35 ms,FA=90,Matrix =64×64,Nex=1,FOV=256 mm,thickness=4 mm,Gap=0,scanning 33 slices。 | 2 times (Before treatment,immediately after treatment) |
| Change from baseline in diffusion tensor imaging (DTI):TR=8500,TE=87, matrix size=64×64, FOV=230, slices thickness = 3 mm, diff directions=30,scanning 46 slices | 2 times (Before treatment,immediately after treatment) |
| Change from baseline in Magnetic Resonance Spectroscopy (MRS) of DMPFC | 2 times (Before treatment,immediately after treatment) |
| Jul 3, 2023 |