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This study aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. At the same time, this study will explore the potential impact of relevant biomarkers and genetic factors on the efficacy of tACS intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACS sham stimulation group | Sham Comparator | The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 0 mA. |
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| tACS Real stimulation group | Experimental | The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 15 mA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hi-tACS | Device | Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Eye Tracking | Binocular saccade amplitude and direction | Day 1 before tACS intervention |
| Eye Tracking | Binocular saccade amplitude and direction | Day 1 after tACS intervention |
| EEG | resting EEG power spectrum | Day 1 before tACS intervention |
| EEG | resting EEG power spectrum | Day 1 after tACS intervention |
| Brief Negative Symptom Scale (Bnss) | The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms. | Day 1 before tACS intervention |
| Brief Negative Symptom Scale (Bnss) | The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms. | Day 4 after tACS intervention |
| MATRICS Consensus Cognitive Battery,MCCB | The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance. | Day 1 before tACS intervention |
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Inclusion Criteria:
Inclusion criteria for long-term hospitalized schizophrenia patients:
Inclusion criteria for normal control group:
Exclusion Criteria:
Exclusion criteria for long-term hospitalization of schizophrenia patients:
Exclusion criteria for normal control group:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pudong New Area Mental Health Center | Shanghai | Shanghai Municipality | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2025 | Jun 30, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2025 | Jun 30, 2025 | ICF_001.pdf |
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| Sham Comparison | Device | Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days |
|
| MATRICS Consensus Cognitive Battery,MCCB |
The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance. |
| Day 4 after tACS intervention |
| The Clinical Assessment Interview Scale | The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms. | Day 1 before tACS intervention |
| The Clinical Assessment Interview Scale | The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms. | Day 4 after tACS intervention |